Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment\r\n* Myelosuppressive chemotherapy: patients must have completely recovered from all acute toxic effects of chemotherapy, immunotherapy or radiotherapy prior to study enrollment; at least 14 days must have elapsed since the completion of cytotoxic therapy, with the exception of hydroxyurea\r\n** Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of protocol therapy\r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\r\n* Biologic (anti-neoplastic agent): at least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur\r\n* Monoclonal antibodies:\r\n** At least 30 days after the completion of any type of immunotherapy, e.g. tumor vaccines \r\n** At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiotherapy:\r\n** >= 2 weeks must have elapsed since local palliative external radiation therapy (XRT) (small port)\r\n** >= 6 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if traumatic brain injury (TBI) was received\r\n** >= 4 weeks must have elapsed if other substantial bone marrow irradiation was given\r\n* Stem cell transplant or rescue without TBI: no evidence of active graft versus (vs.) host disease and >= 3 months must have elapsed since transplantXx_NEWLINE_xXMust not have received therapy with anti-CD20 monoclonal antibodies within 90 days of entry onto this studyXx_NEWLINE_xXMust not have received prior EBV or LMP-specific T cells within 90 days of entry onto this studyXx_NEWLINE_xXMust not have received alemtuzumab or other anti-T-cell antibody therapy within 28 days of entry onto this studyXx_NEWLINE_xXAny major surgery, extensive radiotherapy, chemotherapy with delayed toxicity (e.g. doxorubicin), biologic therapy, or immunotherapy within 21 days prior to enrollment and/or daily or weekly chemotherapy (e.g. sunitinib, sorafenib and pazopanib) without the potential for delayed toxicity within 14 days prior to enrollmentXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** At least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): At least 7 days after the last dose of agent\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* External beam radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after total body irradiation (TBI), craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation.\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days must have elapsed since systemically administered radiopharmaceutical therapy\r\n* Stem cell infusion (with or without TBI):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 100 days after infusion, no evidence of graft versus host disease (GVHD) and no requirement for immunosuppression\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days must have elapsed since the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Patients must not have received prior exposure to nivolumab; for patients enrolled in parts C, D and E, patients must not have received prior nivolumab or ipilimumabXx_NEWLINE_xXPatients must have Barcelona Clinic Liver Cancer (BCLC) stage: intermediate (B) or advanced (C) within 28 days prior to study entryXx_NEWLINE_xXSevere, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months PRIOR TO registration\r\n* Transmural myocardial infarction within the last 6 months prior to study entry\r\n* Unstable ventricular arrhythmia within the last 6 months prior to study entry\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry\r\n* Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 28 days prior to study entry\r\n* Bleeding within 28 days prior to study entry due to any cause, requiring transfusion\r\n* Thrombolytic therapy within 28 days prior to study entry; subcutaneous heparin is permitted\r\n* Known bleeding or clotting disorder\r\n* Uncontrolled psychotic disorderXx_NEWLINE_xXCT or MRI within 14 days prior to start of study drugXx_NEWLINE_xXCorticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroidXx_NEWLINE_xXX ray (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiationXx_NEWLINE_xXPatients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroidXx_NEWLINE_xXPatients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollmentXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days must have elapsed from last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid \r\n* Hematopoietic growth factors: >= 14 days must have elapsed since the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days must have elapsed since the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days must have elapsed after infusion, and no evidence of graft-versus-host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days must have elapsed after completion\r\n* Cellular therapy: >= 42 days must have elapsed since the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* X ray (XRT)/external beam irradiation including protons: >= 14 days must have elapsed after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131 iodine metaiodobenzylguanidine [131I-MIBG]): >= 42 days must have elapsed since systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to LY2606368Xx_NEWLINE_xXCorticosteroids: Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroidXx_NEWLINE_xXOther baseline laboratory evaluations, listed in Section 6.0, must be done within 14 days prior to randomization.Xx_NEWLINE_xXThe subject received any investigational treatment within the past 30 days or prior immunotherapy or antibody therapy within the past 45 days.Xx_NEWLINE_xXCoagulation parameters\t(international normalized ratio [INR], activated partial thromboplastin time [aPTT]) =< 1.25 x institutional limits, except where a lupus anti-coagulant has been confirmed or the patient is on warfarin; patients on full dose anticoagulation must be on a stable dose for at least 14 days. If receiving warfarin, the patient must have an INR =< 3.0 without any evidence of active bleeding within 14 days prior to first dose of study treatment or a pathologic condition that carries a high risk of bleeding (tumor involvement with major blood vessels or varicies), within 28 days prior to administration of study treatmentXx_NEWLINE_xXPatients who have received wide field radiotherapy ? 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to randomizationXx_NEWLINE_xXThrombolytic use (except to maintain i.v. catheters) within 10 days prior to randomizationXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* External beam radiation therapy (XRT): At least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Stem cell infusion without TBI: No evidence of active graft vs. host disease and at least 56 days must have elapsed after transplant or stem cell infusion\r\n* Patients must not have received prior exposure to selinexorXx_NEWLINE_xXAt least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)Xx_NEWLINE_xXAt least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chairXx_NEWLINE_xXPatients must not have received enzyme inducing anticonvulsants for at least 14 days prior to enrollmentXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required time frame, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; at least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea); the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC] counts): >= 7 days after the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial brain metastases (BM) radiation\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-metaiodobenzylguanidine [MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to pevonedistat; patients with prior exposure to irinotecan or temozolomide are eligibleXx_NEWLINE_xXPatients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroidXx_NEWLINE_xXPatients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollmentXx_NEWLINE_xXConcomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugsXx_NEWLINE_xXDiagnosis confirmed on core needle, vacuum-assisted or surgery ? 90 days of registrationXx_NEWLINE_xXPatients must not be receiving or planning to receive trastuzumab; concurrent bisphosphonate therapy is allowed; patients must not have prior exposure to mechanistic target of rapamycin (serine/threonine kinase) (mTOR) inhibitors (rapamycin, everolimus, temsirolimus, deforolimus); patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the studyXx_NEWLINE_xXSerum creatinine level =< IULN within 28 days prior to registrationXx_NEWLINE_xXPatients must have a complete history and physical examination within 28 days prior to registrationXx_NEWLINE_xXRegular nonsteroidal anti-inflammatory drug (NSAID)/aspirin use at any dose (including baby aspirin) (defined as >= 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for 30 days prior to study entry and throughout the study period; participants will be encouraged to use acetaminophen for minor pain and feverXx_NEWLINE_xXNo chronic (duration > 30 days) daily use of oral steroidsXx_NEWLINE_xXPatients must not have received nitrosoureas or mitomycin-C within 42 days prior to sub-study registrationXx_NEWLINE_xXPatients with autoimmune disease who are otherwise eligible must not have received steroid and immunosuppressive therapy within 28 days prior to registrationXx_NEWLINE_xXWithin 28 days prior to registration: Serum creatinine =< 2.0 x IULNXx_NEWLINE_xXSTEP I: Bilirubin =< 1.5 mg/dL (obtained within 28 days prior to randomization)Xx_NEWLINE_xXSTEP II: Bilirubin =< 1.5 mg/dL (within 28 days prior to randomization to Step II)Xx_NEWLINE_xXPatients must not have received any immunotherapy, biologic or any investigational drug within 28 days prior to registration; patients must not have received bevacizumab within 42 days prior to registrationXx_NEWLINE_xXPatients may receive bisphosphonates or denosumab concurrently with study treatment; if started prior to registration, it must be started at least 7 days prior to registrationXx_NEWLINE_xXPlatelet count >= 100,000/ mL within 21 days prior to registration; patients must not have had a blood transfusion within 28 days prior to registrationXx_NEWLINE_xXPatients must have a complete history and physical examination within 28 days prior to registrationXx_NEWLINE_xXPatients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration; patients must have recovered (=< grade 1) from any side effects of prior therapy; patients must not have received any radiation therapy within 14 days prior to sub-study registrationXx_NEWLINE_xXPrestudy history and physical exam must be obtained within 28 days prior to sub-study registrationXx_NEWLINE_xXBrain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to step 2 randomization; eligible patients must be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to step 2 randomizationXx_NEWLINE_xXPatients must have a complete physical examination and medical history within 28 days prior to step 2 randomizationXx_NEWLINE_xXBilirubin =< 1.5 mg/dL within 14 days prior to step 2 randomizationXx_NEWLINE_xXSTEP 3 CROSSOVER REGISTRATION (OPTIONAL): ANC >= 1,500/mcL within 14 days prior to step 3 crossover registrationXx_NEWLINE_xXSTEP 3 CROSSOVER REGISTRATION (OPTIONAL): Platelets >= 75,000/mcL within 14 days prior to step 3 crossover registrationXx_NEWLINE_xXSTEP 3 CROSSOVER REGISTRATION (OPTIONAL): Hemoglobin >= 9 g/dL within 14 days prior to step 3 crossover registrationXx_NEWLINE_xXSTEP 3 CROSSOVER REGISTRATION (OPTIONAL): Bilirubin =< 1.5 mg/dL within 14 days prior to step 3 crossover registrationXx_NEWLINE_xXSTEP 3 CROSSOVER REGISTRATION (OPTIONAL): Calculated creatinine clearance > 30 ml/min within 14 days prior to step 3 crossover registrationXx_NEWLINE_xXPatients must not have received any anti-cancer drug within 28 days prior to registration, and must not have received any nitrosoureas or mitomycin C within 42 days prior to registrationXx_NEWLINE_xXPatients must have lactate dehydrogenase (LDH) obtained within 28 days prior to registration in order to obtain baseline stratification informationXx_NEWLINE_xXPrestudy history and physical must be obtained with 28 days prior to registrationXx_NEWLINE_xXPatients must have dermatology exam obtained within 28 days prior to registration to obtain baseline measurement; exam to be performed by treating physician or designated dermatologistXx_NEWLINE_xXNo treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration; for GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatmentXx_NEWLINE_xXNo treatment with immunotherapy =< 21 days before re-registration; no treatment with biologic therapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before re-registration; no treatment with nitrosourea or mitomycin =< 42 days before re-registrationXx_NEWLINE_xXPatients must have adequate hematologic, liver and renal function =< 28 days prior to randomization\r\n* NOTE: It is preferred that laboratory values for eligibility be assessed after the last dose of prior treatment, especially in cases where most-recent treatment prior to study entry is chemotherapyXx_NEWLINE_xXLeukocytes >= 3000/mm^3 must be obtained =< 7 days prior to protocol registrationXx_NEWLINE_xXPatients must have complete history and physical examination within 28 days prior to registrationXx_NEWLINE_xXSerum creatinine =< 2.0 x IULN within 28 days prior to registrationXx_NEWLINE_xXPatients must also have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension; disease X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; if there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan should be performed at baseline (within 42 days prior to registration); all disease must be assessed and documented on the Baseline Tumor Assessment formXx_NEWLINE_xXPatients with a history of treated brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible; anti-seizure medications are allowed provided they are non-enzyme inducing (e.g. topiramate, levetiracetam, gabapentin)Xx_NEWLINE_xXPatients must have a complete physical examination and medical history within 28 days prior to registrationXx_NEWLINE_xXREGISTRATION STEP 2-RANDOMIZATION: Patients must be registered to Step 2 no more than 42 days after registration to Step 1 and no more than 42 days after collection of specimens for FLT3 testingXx_NEWLINE_xXREGISTRATION STEP 2-RANDOMIZATION: Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 42 days prior to randomization (registration Step 2); reports of the results must be submittedXx_NEWLINE_xXREGISTRATION STEP 2-RANDOMIZATION: Patients may have received non-intensive therapy for antecedent hematologic disorders, including lenalidomide; patients may have received prior chemotherapy for prior cancers; these therapies must be discontinued at least 5 days prior to randomization (registration to Step 2)Xx_NEWLINE_xXREGISTRATION STEP 2-RANDOMIZATION: The following tests must be performed within 14 days prior to randomization (registration to Step 2) to establish baseline values:\r\n* Performance status\r\n* Complete blood count (CBC)/differential/platelets\r\n* Creatinine clearance (Cockcroft-Gault)\r\n* Total bilirubin\r\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\r\n* Lactate dehydrogenase (LDH)\r\n* Albumin\r\n* Glucose\r\n* Fibrinogen\r\n* Electrocardiogram (ECG)Xx_NEWLINE_xXREGISTRATION STEP 2-RANDOMIZATION: Patients must have complete history and physical examination within 28 days prior to randomization (registration to Step 2); history must include autoimmune disease status (to determine whether patient is eligible for Arm B)Xx_NEWLINE_xXAll tests for establishing baseline values must be completed within 14 days prior to registration to Step 2 (randomization)Xx_NEWLINE_xXNo treatment with biological therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registrationXx_NEWLINE_xXPatient history: patients who have any of the following are NOT eligible:\r\n* Central nervous system (CNS): Symptomatic, untreated, or uncontrolled brain metastases present\r\n* Heme: Active bleeding or bleeding diathesis\r\n* Gastrointestinal (GI):\r\n** Abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to registration\r\n** Acute GI bleed within 28 days of registration\r\n* Diabetes mellitus: Patients with diabetes mellitus with inadequate control, based on either a glycosylated hemoglobin (Hgb A1c) of > 7.0 or fasting blood glucose above or equal to 130 mg/dL\r\n* Cardiac and vascular disorders:\r\n** History of congenital long QT syndrome or torsades de pointes\r\n** Any arrhythmia that is currently not rate-controlled (rate between 60 and 100)\r\n** Prolongation of corrected QT interval via Fridericia’s formula (QTcF) > 480 msec\r\n** Ongoing unstable angina\r\n** Symptomatic peripheral vascular disease\r\n** Arterial thrombosis within 28 days of registration including transient ischemic attack (TIA), cerebrovascular accident (CVA), myocardial infarction (MI)\r\n** Patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) must be on a stable dose of anticoagulation for 14 days prior to registration\r\n** Uncontrolled hypertension, defined as blood pressure (BP) > 140/90\r\n** Multi gated acquisition scan (MUGA) with ejection fraction (EF), 50% or echocardiogram (echo) with low EF\r\n** Class III or IV congestive heart failure (CHF) within 28 days of registrationXx_NEWLINE_xXChronic concomitant treatment with proton pump inhibitors must discontinue the drug for 7 days prior to registration on the studyXx_NEWLINE_xXPatients must have complete history and physical examination within 28 days prior to registrationXx_NEWLINE_xXA serum thyroid-stimulating hormone (TSH) must be obtained within 28 days prior to step 2 registration to obtain a baseline valueXx_NEWLINE_xXHistory/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registrationXx_NEWLINE_xXBaseline serum PSA value performed with a Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registrationXx_NEWLINE_xXStudy entry PSA should not be obtained during the following time frames:             \r\n* 10-day period following prostate biopsy\r\n* Following initiation of hormonal therapy\r\n* Within 30 days after discontinuation of finasteride\r\n* Within 90 days after discontinuation of dutasterideXx_NEWLINE_xXUse of finasteride within 30 days prior to registrationXx_NEWLINE_xXUse of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registrationXx_NEWLINE_xXWithin less than or equal to 14 days prior to registration: Glycosylated hemoglobin (HbA1c) < 7.0%Xx_NEWLINE_xXPatients CANNOT have daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drugXx_NEWLINE_xXNo lytic lesions on skeletal survey and whole body PET/CT other than a single lesion associated with solitary bone plasmacytoma within 28 days prior to registrationXx_NEWLINE_xXFor all forms of systemic therapy, patients must have completed therapy at least 21 days prior to registration; patients must have completed any radioimmunotherapy at least 84 days prior to registration; patients must have recovered from all treatment related toxicities from these therapies prior to registrationXx_NEWLINE_xXDirect bilirubin =< 1.5 x IULN (=< 5 x IULN if secondary to lymphoma) within 28 days prior to registrationXx_NEWLINE_xXPatients must have a complete history and physical examination within 28 days prior to registrationXx_NEWLINE_xXPrior androgen deprivation (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to study enrollment and given for =< 90 days duration\r\n* For example: Patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug; for instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date; for a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date\r\n* Please note: Finasteride or dutasteride must be stopped before treatment but should not determine eligibilityXx_NEWLINE_xXProstatectomy performed greater than 365 days (1 year) prior to step 1 registrationXx_NEWLINE_xXSigns or symptoms of infection within 14 days prior to randomizationXx_NEWLINE_xXBiologic (anti-neoplastic) agent: at least 7 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occurXx_NEWLINE_xXPrior therapy\r\n* Patients =< 30 days from the last dose of cytarabine used for treatment of TMDXx_NEWLINE_xXNo investigational therapy within 14 days prior to registrationXx_NEWLINE_xXPatient must have negative lumbar cerebrospinal fluid (CSF) cytology; CSF cytology for staging should be performed preferably no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study\r\n* Note: patients with positive CSF cytology obtained prior to 14 days after surgery may have cytology repeated to determine eligibility and final CSF statusXx_NEWLINE_xXPRIOR TO STEP 1 REGISTRATIONXx_NEWLINE_xXPRIOR TO STEP 2 REGISTRATIONXx_NEWLINE_xXHistory/physical examination within 28 days prior to step 2 registrationXx_NEWLINE_xXDocumentation of steroid doses within 28 days prior to step 2 registrationXx_NEWLINE_xXComplete blood count (CBC)/differential obtained within 28 days prior to step 2 registrationXx_NEWLINE_xXPatents treated on any other therapeutic clinical protocols within 30 days prior to step 2 registrationXx_NEWLINE_xXPatients must not have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registrationXx_NEWLINE_xXPatients must have lactate dehydrogenase (LDH) performed within 28 days prior to registrationXx_NEWLINE_xXPatient has not received more than 14 days of multiagent induction therapy beginning with the first dose of vinCRIStineXx_NEWLINE_xXPatient may have started imatinib prior to study entry but has not received more than 14 days of imatinibXx_NEWLINE_xXBlood cell count (CBC)/differential obtained within 60 days prior to registration on studyXx_NEWLINE_xXHistory/physical examination within 90 days prior to Step 1 registrationXx_NEWLINE_xXPrior androgen deprivation therapy (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to Step 1 registration and given for =< 90 days duration\r\n* For example: patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug; for instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date; for a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date \r\n* Please note: finasteride or dutasteride must be stopped before treatment starts but prior usage will not affect eligibilityXx_NEWLINE_xXFor patients who have not undergone prior Decipher analysis, submission of the specimen to GenomeDx should be as soon as possible after study registration (Step 1) as these results can take up 21 days after the specimen is received at GenomeDx; Step 2 registration must occur within 6 weeks (42 days) of Step 1 registration; if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validationXx_NEWLINE_xXAll patients with T1 urothelial carcinoma must undergo re-transurethral resection of bladder tumor (TURBT) within 60 days prior to registration, and must have uninvolved muscularis propria in the pathologic specimen from either the first or the second TURBT; tissue from the re-resection must be submitted; the TURBT that identified the recurrent T1 disease may have taken place more than 60 days prior to registrationXx_NEWLINE_xXPatients must have a baseline electrocardiograph (ECG) performed within 42 days prior to registrationXx_NEWLINE_xXHistory and physical including a digital rectal exam 60 days prior to registrationXx_NEWLINE_xXBone scan as clinically indicated within 90 days prior to registrationXx_NEWLINE_xXCharlson modified co-morbidity score =< 3 for patients under 60 and =< 4 for patients 60 and over 21 days prior to registrationXx_NEWLINE_xXInternational prostate symptom score (IPSS) of < 15 21 days prior to registrationXx_NEWLINE_xXCompletion of all items of the EPIC-26 which will be data entered at registration 60 days prior to registrationXx_NEWLINE_xXPatients must have had all grossly visible papillary tumors removed within 30 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to registrationXx_NEWLINE_xXPrestudy history and physical must be obtained within 90 days prior to registration; patients must have a complete blood count (CBC) and basic metabolic panel including creatinine, potassium, chloride, blood urea nitrogen (BUN), carbon dioxide (CO2) and glucose within 28 days prior to registrationXx_NEWLINE_xXPatients must have postoperative predicted forced expiratory volume (FEV) > 35% prior to surgery obtained within 28 days prior to step 2 registrationXx_NEWLINE_xXPatients must have postoperative oxygen consumption (VO2) max > 15 ml/kg/min prior to surgery obtained within 28 days prior to step 2 registrationXx_NEWLINE_xXPatient must be registered to step 2 no less than 21 days and no more than 90 days after the end of their final cycle of neoadjuvant therapyXx_NEWLINE_xXPatient must have received either P/D or EPP and must have recovered from all effects of surgery with adequate wound healing; patients who received radiation therapy (RT) must be registered to step 3 within 28 days after discontinuing RT; patients who did not receive RT must be registered to step 3 within 56 days after surgeryXx_NEWLINE_xXCreatinine < 1.5 x ULN documented within 28 days prior to step 3 registrationXx_NEWLINE_xXPatients must have complete history and physical examination within 28 days prior to registrationXx_NEWLINE_xXPatients must have total bilirubin =< 2.0 x IULN within 14 days prior to registrationXx_NEWLINE_xXPatients must not have testicular involvement; if clinical or ultrasound findings are equivocal, biopsy must be performed; all tests for establishing testicular involvement must be completed within 14 days prior to registrationXx_NEWLINE_xXPatients must NOT have received a prior autologous or allogeneic hematopoietic stem cell transplant at any time. Patients must NOT have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration, with the following exceptions:\r\n* Monoclonal antibodies must not have been received for 1 week prior to registration\r\n* Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration\r\n* Steroids, hydroxyurea, vincristine, 6-mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any timeframe prior to registration; Food and Drug Administration (FDA)-approved TKIs may also be administered until 1 day prior to start of study therapy (C1, D1); IV cyclophosphamide may be administered at doses of 1 g/m^2 or less until up to 7 days prior to registrationXx_NEWLINE_xXPatients must have QTcF (by Fridericia calculation) < 480/msec based on electrocardiogram (EKG) performed within 28 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< 2.0 x IULN within 14 days prior to registrationXx_NEWLINE_xXRegistration Step 3 – Maintenance: Patients must have adequate marrow function as evidenced by ANC >= 750/mcl within 28 days prior to registrationXx_NEWLINE_xXPRIOR TO STEP 1 REGISTRATION:Xx_NEWLINE_xXPRIOR TO STEP 2 REGISTRATION:Xx_NEWLINE_xXHistory/physical examination, including neurologic examination within 60 days prior to step 2 registrationXx_NEWLINE_xXPatients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroidXx_NEWLINE_xXPatients must not have received enzyme–inducing anticonvulsants within 14 days prior to enrollmentXx_NEWLINE_xXPatients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, or open biopsy within 28 days prior to enrollment\r\n* Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines (e.g., Hickman or Broviac catheter, peripherally inserted central catheter [PICC]) and at least 7 days prior to enrollment for a subcutaneous port\r\n* Core biopsy within 7 days prior to enrollment\r\n* Fine needle aspirate within 7 days prior to enrollment\r\n* Surgical or other wounds must be adequately healed prior to enrollment\r\n* NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapyXx_NEWLINE_xXHistory/physical examination within 21 days prior to study entryXx_NEWLINE_xXPrior lapatinib is allowed as long as the last dose received was > 21 days prior to study entry and provided the patient has not received it at any time after the diagnosis of brain metastasisXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n** Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131iodine [I]-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to olaparib, veliparib, niraparib, rucaparib, talazoparib or other poly adenosine diphosphate ribose polymerase inhibitors (PARPi)Xx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* X-ray therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n** Note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to JNJ-42756493 (erdafitinib) or another FGFR inhibitor such as (but not limited to) AZD4547, BGJ398, BAY1163877, LY2874455Xx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total-body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to a BRAF inhibitor (e.g. vemurafenib, dabrafenib or encorafenib)Xx_NEWLINE_xXPatients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroidXx_NEWLINE_xXNo previous chemotherapy within 16 days prior to enrollment except for bleomycin which cannot have been given within 5 days prior to enrollmentXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >=14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial none marrow (BM) radiation\r\n** Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to ensartinib; prior treatment with other ALK inhibitors is permitted given that at least 5 half-lives or 21 days have elapsed since therapy discontinuation, whichever is greaterXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required time frame, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\t\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or ANC counts): >= 7 days after the last dose of agent; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor leukocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial brain metastases (BM) radiation; Note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to other NTRK inhibitors including but not limited to LOXO-101 (larotrectinib), entrectinib (RXDX-101), DS6051, PLX7486Xx_NEWLINE_xXPatients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroidXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n** Note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to LY3023414\r\n* Patients must not have received prior exposure to an agent specifically directed at the PI3K/MTOR pathway (a PI3K inhibitor, an AKT inhibitor, an MTOR inhibitor, including rapalogs, or a combined PI3K/MTOR inhibitor)Xx_NEWLINE_xXCYP3A isoenzymes within 7 days of randomization.Xx_NEWLINE_xXUse of any investigational drugs, biologics, or devices within 30 days prior or during the study treatment.Xx_NEWLINE_xXThrombolytic use within 10 days prior to first day of study therapyXx_NEWLINE_xXPatients with whole blood transfusion in the last 120 days prior to entry to the studyXx_NEWLINE_xXPrior or concomitant treatments:\r\n* Prior treatment with ibrutinib\r\n* The following cancer treatments:\r\n** Chemotherapy or biological therapy within 14 days prior to start of treatment\r\n** Immunological therapy, radiation therapy, or hormonal therapy within 7 days prior to start of treatment\r\n** Major surgery within 15 days prior to start of treatment\r\n** Subjects who have unresolved toxicity (>= grade 2) from prior anti-cancer therapy, unless that event is thought to be due to disease progression\r\n* Any investigational agent, including small molecule agents, within 30 days prior to start of study treatment\r\n* Any of the following with 7 days prior to start of study treatment:\r\n** B-cell receptor pathway inhibitor;\r\n** CYP3A inhibitors (such as fluconazole, ketoconazole, and clarithromycin);\r\n** Potent CYP3A inducers (e.g., rifampin, phenytoin, carbamazepine or St. John's wort);\r\n** Warfarin or requires the use of warfarin (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of this effect);\r\n** Antiretroviral medications\r\n** Antibiotics, antifungals, or antivirals to treat an active infection (prophylactic antibiotics allowed)\r\n* Subjects who are unable or unwilling to discontinue use of prohibited medications, including medications with CYP450 interactions\r\n* Subject has received prior treatment with allogeneic stem cell transplant or solid organ transplant (except for cornea) for any indicationXx_NEWLINE_xXIntake of any herbal preparations or medications (including, but not limited to, Saint John’s wort and ginkgo biloba) and dietary supplements within 7 days prior to first dose of study drugXx_NEWLINE_xXPatients must not have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration with the following exceptions:\r\n* Monoclonal antibodies must not have been received for 1 week prior to registration\r\n* Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration\r\n* Steroids, hydroxyurea, vincristine, 6-mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any time frame prior to registration; Food and Drug Administration (FDA)-approved tyrosine kinase inhibitors may also be administered until 1 day prior to start of study therapy (cycle 1 [C1], day 1 [D1])\r\n* All drug-related toxicities must have resolved to =< grade 2Xx_NEWLINE_xXPatients must have a peripheral blast count < 25,000/uL within 2 days prior to registration; (treatment with hydroxyurea and steroids is permitted to bring the countdown)Xx_NEWLINE_xXPatients must have bilirubin =< 2 x IULN within 7 days prior to registration (unless the bilirubin is primarily unconjugated)Xx_NEWLINE_xXPatients must have complete history and physical examination within 28 days prior to registrationXx_NEWLINE_xXInclusion Criteria\n\n        All Subjects:\n\n          1. Phase 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n\n             Phase 2: ECOG performance status of 0 to 2.\n\n          2. Life expectancy ? 3 months before starting tazemetostat.\n\n          3. Subjects with Hepatitis B or C are eligible on the condition that subjects have\n             adequate liver function as defined by Inclusion Criterion #6 and are hepatitis B\n             surface antigen negative and/or have undetectable hepatitis C virus (HCV) RNA.\n\n          4. Adequate renal function defined as calculated creatinine clearance greater than or\n             equal to 40 mL/min per the Cockcroft and Gault formula or the local institutional\n             standard formula.\n\n          5. Adequate bone marrow function:\n\n               1. Absolute neutrophil count (ANC) ?750/mm3 (?0.75 x 10^9/L) - Without growth factor\n                  support (filgrastim or pegfilgrastim) for at least 14 days\n\n               2. Platelets greater ? 75,000/mm3 (?75 x 10^9/L) - Evaluated after at least 7 days\n                  since last platelet transfusion\n\n               3. Hemoglobin greater than or equal to 9.0 g/dL - May receive transfusion\n\n          6. Adequate liver function:\n\n               1. Total bilirubin less than or equal to 1.5 x the upper limit of normal (ULN)\n                  except for unconjugated hyperbilirubinemia of Gilbert's syndrome\n\n               2. Alkaline phosphatase (ALP) (in the absence of bone disease), alanine\n                  aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal\n                  to 3 x ULN (less than or equal to 5 x ULN if subject has liver metastases)\n\n          7. Time between prior anticancer therapy and first dose of tazemetostat as below:\n\n               1. Cytotoxic chemotherapy - At least 21 days\n\n               2. Non-cytotoxic chemotherapy (eg. Small molecule inhibitor) - At least 14 days\n\n               3. Nitrosoureas - At least 6 weeks\n\n               4. Monoclonal antibody (ies) - At least 28 days\n\n               5. Radiotherapy- At least 14 days from local site radiation therapy/At least 6 weeks\n                  from prior radioisotope therapy/At least 12 weeks from 50% pelvic or total body\n                  irradiation\n\n               6. High dose therapy with autologous hematopoietic cell infusion - At least 60 days\n\n               7. High dose therapy with allogeneic transplant - At least 90 days (if graft versus\n                  host disease [GVHD] is present, must be < Grade 2) and no prohibited medications\n                  per Exclusion Criteria #3)\n\n             Note: Starting at Cycle 1 Day 1, subjects may receive no more than 10 mg of prednisone\n             daily (or equivalent corticosteroid, excluding protocol-defined prednisolone dosing\n             for subjects enrolled in Cohort 6) when used for treatment of lymphoma related\n             symptoms, with the intent to taper by the end of Cycle 1.\n\n          8. Males or females aged ? 18 years at the time of informed consent (Phase 2). Males and\n             females aged ? 16 years at time of informed consent (Phase 1).\n\n          9. Females must not be lactating or pregnant at screening or baseline (as documented by a\n             negative beta-human chorionic gonadotropin [beta-hCG] test with a minimum sensitivity\n             of 25 IU/L or equivalent units of beta-hCG). A separate baseline assessment is\n             required if a negative screening pregnancy test was obtained more than 72 hours before\n             the first dose of study drug. All females will be considered to be of childbearing\n             potential unless they are postmenopausal (at least 12 months consecutive amenorrheic,\n             in the appropriate age group, and without other known or suspected cause) or have been\n             sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral\n             oophorectomy, all with surgery at least 1 month before dose). Females of childbearing\n             potential must not have had unprotected sexual intercourse within 30 days prior to\n             study entry and must agree to use a highly effective method of contraception, from the\n             last menstrual period prior to randomization, during Treatment Cycles, and for 30 days\n             after the last final dose of study treatment, and have a male partner who uses a\n             condom. Highly effective contraception includes:\n\n               1. Double barrier methods of contraception such as condom plus diaphragm or\n                  cervical/vault cap with spermicide.\n\n               2. Placement of an intrauterine device.\n\n               3. Established hormonal contraceptive methods: oral, injectable, or implant. Females\n                  who are using hormonal contraceptives must have been on a stable dose of the same\n                  hormonal contraceptive product for at least 4 weeks prior to dosing and must\n                  continue to use the same contraceptive during the study and for 30 days after\n                  study drug discontinuation.\n\n             Female subjects exempt from this requirement are subjects who practice total\n             abstinence or have a male partner who is vasectomized. If currently abstinent, the\n             subject must agree to use a highly effective method of contraception as described\n             above if they become sexually active during the Treatment Cycles, and for 30 days\n             after study drug discontinuation.\n\n         10. Male subjects must have had a successful vasectomy or they and their female partner\n             must meet the criteria above (ie, not of childbearing potential or practicing highly\n             effective contraception and use a condom throughout the study period and for 30 days\n             after study drug discontinuation).\n\n         11. Voluntary agreement to provide written informed consent and the willingness and\n             ability to comply with all aspects of the protocol.\n\n             Phase 1 only:\n\n         12. Histologically and/or cytologically confirmed advanced or metastatic solid tumor or\n             B-cell lymphomas that have progressed after treatment with approved therapies or for\n             which there are no standard therapies available.\n\n             Phase 2 only:\n\n         13. Subjects must satisfy all of the following criteria:\n\n               1. Have histologically confirmed DLBCL (including primary mediastinal B-cell\n                  lymphoma), with relapsed or refractory disease following at least 2 lines of\n                  prior standard therapy, including alkylator/anthracycline (unless\n                  anthracycline-based chemotherapy is contraindicated)/anti-CD20-based therapy\n                  (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone\n                  [R-CHOP] or equivalent) AND must be considered unable to benefit from\n                  intensification treatment with autologous hematopoietic stem cell transplantation\n                  (ASCT) as defined by meeting at least 1 of the following criteria:\n\n                    -  Relapsed following, or refractory to, previous ASCT\n\n                    -  Did not achieve at least a partial response to a standard salvage regimen\n                       (eg, rituximab, ifosfamide, carboplatin, and etoposide phosphate [R-ICE] or\n                       rituximab, dexamethasone, cytarabine, and cisplatin [R-DHAP])\n\n                    -  Ineligible for intensification treatment due to age or significant\n                       comorbidity\n\n                    -  Ineligible for intensification treatment due to failure to mobilize an\n                       acceptable number of hematopoietic stem cells\n\n                    -  Refused intensification treatment and/or ASCT\n\n                  OR have histologically confirmed FL. Subjects may have relapsed/refractory\n                  disease following at least 2 standard prior treatment regimens, including at\n                  least 1 anti-CD20-based regimen, as well as alkylating agents (eg,\n                  cyclophosphamide or bendamustine), and have no curative option with other\n                  available therapies OR have a contra-indication to their use. Subjects with prior\n                  ASCT may be included.\n\n               2. Have provided sufficient archival tumor tissue that has been successfully tested\n                  for EZH2 mutation status and cell of origin (DLBCL only) at study specific\n                  laboratories allowing for allocation into an open cohort.\n\n               3. Have measurable disease as defined by International Working Group-Non-Hodgkin's\n                  Lymphoma (IWG-NHL [Cheson, 2007]).\n\n        Exclusion Criteria\n\n        All Subjects:\n\n          1. Prior exposure to tazemetostat or other inhibitor(s) of EZH2.\n\n          2. Subjects with leptomeningeal metastases or brain metastases or history of previously\n             treated brain metastases.\n\n          3. Subjects taking medications that are known potent CYP3A4 inducers/inhibitors\n             (including St. Johns Wort) (see\n             http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteracti\n             onsLabeling/ucm080499.htm; http://medicine.iupui.edu/clinpharm/ddis/)\n\n          4. Subjects unwilling to remove Seville oranges, grapefruit juice and grapefruit from\n             their diet.\n\n          5. Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy)\n             clinically significant toxicities have not resolved to ? Grade 1 per CTCAE version\n             4.03 or prior treatment-related toxicities are clinically unstable and clinically\n             significant at time of enrollment.\n\n          6. Major surgery within 4 weeks before the first dose of study drug.\n\n             Note: Minor surgery (eg. minor biopsy of extracranial site, central venous catheter\n             placement, shunt revision) is permitted within 3 weeks prior to enrollment.\n\n          7. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled\n             gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the\n             bioavailability of tazemetostat.\n\n          8. Significant cardiovascular impairment: history of congestive heart failure greater\n             than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension,\n             unstable angina, myocardial infarction, or stroke within 6 months of the first dose of\n             study drug; or cardiac ventricular arrhythmia.\n\n          9. Prolongation of corrected QT interval using Fridericia's formula (QTcF) to > 480 msec.\n\n         10. Venous thrombosis or pulmonary embolism within the last 3 months before starting\n             tazemetostat.\n\n         11. Active infection requiring systemic therapy.\n\n         12. Known hypersensitivity to any component of tazemetostat, prednisolone/prednisone\n             (combination cohort only), or inability to be treated with a Pneumocystis prophylaxis\n             medication (combination cohort only).\n\n         13. Immunocompromised patients, including patients known to be infected with human\n             immunodeficiency virus (HIV).\n\n         14. Any other major illness that, in the investigator's judgment, will substantially\n             increase the risk associated with the subject's participation in this study.\n\n         15. Females who are pregnant or breastfeeding.\n\n         16. Subjects who have undergone an organ transplant.\n\n             Phase 2 only:\n\n         17. Subjects with noncutaneous malignancies other than B-cell lymphomas. Exception:\n             Subjects with another malignancy who have been disease-free for 5 years, or subjects\n             with a history of a completely resected non-melanoma skin cancer or successfully\n             treated in situ carcinoma are eligible.Xx_NEWLINE_xXPatients who have had a transfusion within 7 days of screening are NOT eligible for participationXx_NEWLINE_xXFemale subjects who are lactating must discontinue nursing prior to the first dose of study drug and refrain from nursing throughout the treatment period and for 14 days following the last dose of study drugXx_NEWLINE_xXAutologous blood transfusion within last 30 days or plan to donate autologous blood prior to surgeryXx_NEWLINE_xXAt the time of registration: patients must have recovered from the toxic effects of prior therapy: >= 28 days from any investigational agent, >= 28 days from prior cytotoxic therapy, >= 14 days from vincristine, >= 42 days from nitrosoureas, >= 21 days from procarbazine administration, and >= 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count); any questions related to the definition of non-cytotoxic agents should be directed to the principal investigatorXx_NEWLINE_xXPatients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: \r\n* They have recovered from the effects of surgery\r\n* A minimum of 28 days have elapsed from the day of surgery to the day of registration step 2; for core or needle biopsy, a minimum of 7 days must have elapsed prior to registration step 2\r\n* Residual disease following resection of recurrent ependymoma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to consent; if the \within 96-hour after surgery\ scan is more than 14 days before consent, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and consent, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 daysXx_NEWLINE_xXPatients must be enrolled before treatment begins; the date protocol therapy is to start must be no later than 42 days from the time of recurrence and within 7 days from enrollmentXx_NEWLINE_xXA MRI of the spine is required within 10 days prior to or at least 10 days after surgeryXx_NEWLINE_xXSerum HCGbeta and AFP levels must be assessed within 7 days prior to registrationXx_NEWLINE_xXPatient must have lumbar CSF for cytology, protein, AFP and HCGbeta within 7 days prior to registrationXx_NEWLINE_xXMust not have received any biological modifier within 14 days of entry on to this studyXx_NEWLINE_xXLiver function test must be obtained within 14 days prior to registrationXx_NEWLINE_xXSubjects must be =< 90 days from diagnosis of PCNSL in the brain or spine; time from pathologic diagnosis to initiation of treatment should be specified; subjects with history of only ocular lymphoma are eligible if < 90 days since documented brain parenchymal disease (by imaging or by biopsy)Xx_NEWLINE_xXReceipt of previous approved or investigative immune modulatory agent within 28 days of receiving the first dose of treatment;Xx_NEWLINE_xXPRIOR TO STUDY ENROLLMENTXx_NEWLINE_xXPatients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days if nitrosoureaXx_NEWLINE_xXReceipt of an EGFR TKI within 14 days of the first dose of study treatment.Xx_NEWLINE_xXScreening laboratory values must meet the following criteria and should be obtained within 30 days (or 45 days if a biopsy is repeated) prior to study treatment:Xx_NEWLINE_xXSerum total bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction) (within 14 days of treatment initiation)Xx_NEWLINE_xXIndication A only: at least 2 measurable lesions as defined per modified RECIST 1.1 within 28 days prior to the first dose of AMG 757Xx_NEWLINE_xXPrior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of AMG 757 Exceptions: Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade .1 Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757Xx_NEWLINE_xXParticipation in other studies involving investigational drug(s) within 28 days prior to study entry.Xx_NEWLINE_xXHospitalization for more than 2 days for documented febrile neutropenia, pneumonia, sepsis, or systemic infection in the 30 days before screening.Xx_NEWLINE_xXAll Cohort A Dose Escalation Participants:\r\n* Prior hormonal therapy: Participants may have received any number of previous endocrine / hormonal lines of therapy in the metastatic setting (including prior fulvestrant), as long as the last dose is >= 14 days prior to first dose of study treatment\r\n* Prior biologics / investigational therapy: Prior therapy with biologics and investigational drugs is allowed, as long as the last dose is >= 21 days prior to first dose of study treatment\r\n* Prior CDK4/6 inhibition is allowed; participants who have had prior ribociclib must have received treatment at full-dose without any dose reductions; the last dose is required to be >= 21 days prior to first dose of study treatment\r\n* Treatment with prior PD1/PDL1/CTLA4 inhibitors is prohibited\r\n* Prior radiotherapy: Participants may have received radiotherapy for palliative purposes but must have completed treatment ? 14 days prior to first dose of study treatment and not be experiencing grade > 1 treatment-related toxicities\r\n* Evaluable or measurable disease by RECIST 1.1Xx_NEWLINE_xXCohort B Safety Run-In (Ribociclib + PDR001 + Fulvestrant): Prior biologics / investigational therapy: \r\n* Prior therapy with biologics and investigational drugs is allowed, as long as the last dose is >= 21 days prior to first dose of study treatmentXx_NEWLINE_xXCohort A Dose Expansion (Ribociclib + PDR001): Prior biologics / investigational therapy: \r\n* Prior therapy with biologics and investigational drugs is allowed, as long as the last dose is >= 21 days prior to first dose of study treatmentXx_NEWLINE_xXExpansion Cohort B (Ribociclib + PDR001 + Fulvestrant): Prior biologics / investigational therapy:\r\n* Prior therapy with biologics and investigational drugs is allowed, as long as the last dose is >= 21 days prior to first dose of study treatmentXx_NEWLINE_xXStable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatmentXx_NEWLINE_xXNo craniotomy within 21 days of registrationXx_NEWLINE_xXMust start the study treatment no more than 60 days from the last dose of RT (if administered) and no more than 120 days from the date of surgical removal of nodal metastasesXx_NEWLINE_xXAny prior intra-lesional MCC therapy within 180 days from day 1 of study treatmentXx_NEWLINE_xXESA use of less than 28 days and no ESA within the 12 weeks prior to randomizationXx_NEWLINE_xXDexamethasone: 7 daysXx_NEWLINE_xXThalidomide: 7 daysXx_NEWLINE_xXPamolidomide: 7 daysXx_NEWLINE_xXBortezomib: 7 daysXx_NEWLINE_xXCarfilzomib: 7 daysXx_NEWLINE_xXG-CSF: 14 daysXx_NEWLINE_xXGM-CSF or Neulasta®: 21 daysXx_NEWLINE_xXErythropoietin or erythrocyte stimulating agents: 30 daysXx_NEWLINE_xXEltrombopag, romiplostim or platelet stimulating agents: 30 daysXx_NEWLINE_xXReceived G-CSF within 14 days prior to anticipated first dose of G-CSF.Xx_NEWLINE_xXReceived erythrocyte of platelet stimulating agents within 30 days prior to anticipated first dose of G-CSFXx_NEWLINE_xXRegistration must be completed =< 28 days of pre-registrationXx_NEWLINE_xXAnticipated use of any concomitant medication during or within 7 days before initiation of study treatment that is known to cause QT prolongationXx_NEWLINE_xXAt least 7 days must have passed after the last treatment with a biologic agent; for agents that have known adverse events occurring beyond 7 days from administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chairXx_NEWLINE_xXPatients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligibleXx_NEWLINE_xXAny chemotherapy within the 28 days prior to the first dose of study drug.Xx_NEWLINE_xXTamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug.Xx_NEWLINE_xXFulvestrant within 30 days prior to first dose of study drug.Xx_NEWLINE_xXConcurrent use or anticipated need for medications that are mainly metabolized by UGT1A9 including their administration within 7-days prior to the first dose of study drug (e.g., raloxifene, valproic acid, propofol, propranolol, dapagliflozin, darexaban, mycophenolic acid, and tapentadol)Xx_NEWLINE_xXParticipant must not have current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).Xx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).Xx_NEWLINE_xXBiologic (anti-neoplastic agent): patients must be at least 7 days since the completion of therapy prior to registrationXx_NEWLINE_xXStable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatmentXx_NEWLINE_xXHave used or plan to use from 30 days prior to enrollment through the end of the study medication known to lower the seizure threshold or prolong the QT intervalXx_NEWLINE_xXInclusion Criteria:\n\n        Phase Ib subjects must meet the following inclusion criteria:\n\n          -  Locally advanced urothelial cancer of bladder with any of the following:\n\n               1. T3-4, N0-2 M0, OR Tx N1-2 M0 OR T2 N1-2 M0: Treatment naïve, unresectable, OR\n                  medically unfit for surgery, OR cisplatin ineligible. T3 N0 M0 patients can be\n                  included if they are cisplatin ineligible.\n\n               2. Patients who have T3-4, N0-2 M0 OR Tx N1-2 M0 OR T2 N1-2 M0 post-neoadjuvant\n                  chemotherapy who become unresectable OR medically unfit for surgery.\n\n                  Phase II subjects must meet the following inclusion criteria:\n\n          -  Locally advanced urothelial cancer of bladder with any of the following:\n\n               1. T3-4, N0-2 M0 OR Tx N1-2 M0 OR T2 N1-2 M0: Treatment naïve, unresectable, OR\n                  medically unfit for surgery OR cisplatin ineligible. T3 N0 M0 patients can be\n                  included if they are cisplatin ineligible.\n\n               2. T3-4, N0-1 M0 OR Tx N1-2 M0 OR T2 N1-2 M0 patients post-neoadjuvant chemotherapy\n                  who become unresectable OR medically unfit for surgery.\n\n          -  T2, N0, M0 who are ineligible to get cisplatin based chemotherapy.\n\n        All subjects:\n\n          -  Written informed consent and HIPAA authorization for personal health information,\n             obtained from the subject prior to performing any protocol-related procedures,\n             including screening evaluations.\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n\n          -  Life expectancy of >6 months per treating physician.\n\n          -  Subjects must have archival tissue available from previous TURBT (preferred) or lymph\n             node core biopsy within 8 weeks of treatment or be assessed by the treating urologist\n             to undergo maximal TURBT. The extent of TURBT may vary for each patient and will be\n             determined by the treating urologist. Further, the treating urologist will decide if\n             performing the TURBT is clinically appropriate. If the potential subject does not have\n             tumor amenable to biopsy, there is insufficient tissue for PD-L1 testing or is not\n             clinically appropriate for TURBT, enrollment must be discussed with the\n             sponsor-investigator on a case by case basis.\n\n          -  Histologically proven urothelial carcinoma of bladder with predominant transitional\n             cell component. Adenocarcinoma, squamous cell differentiation, or other atypical\n             histology (such as plasmacytoid or sarcomotoid) of the bladder will be allowed on the\n             study, provided they form <50% of the histology.\n\n          -  Females of childbearing potential must have a negative urine and serum pregnancy test\n             within 3 days of study registration.\n\n        NOTE: Female subjects are considered of child bearing potential unless they are surgically\n        sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral\n        oophorectomy) or they are ?60 years old and naturally postmenopausal for at least 12\n        consecutive months.\n\n          -  Subject is willing and able to comply with the protocol for the duration of the study\n             including undergoing treatment and scheduled visits and examinations including follow\n             up.\n\n        Exclusion Criteria:\n\n          -  Involvement in the planning and/or conduct of the study (applies to both AstraZeneca\n             staff and/or staff at the study site).\n\n          -  Participation in another clinical study with an investigational product within 2 weeks\n             prior to registration.\n\n          -  Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.\n\n          -  Previous systemic immunotherapy. Previous use of intravesical BCG is acceptable.\n\n          -  History of another primary malignancy except for:\n\n               1. Malignancy treated with curative intent and with no known active disease ?5 years\n                  before the first dose of study drug and of low potential risk for recurrence.\n                  However adequately treated prostate cancer >3 years ago with no significant\n                  change in PSA for past 6 months can be included. Patients with a history of\n                  prostate cancer must not have any definitive radiation therapy to prostate area.\n\n               2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence\n                  of disease.\n\n               3. Adequately treated carcinoma in situ without evidence of disease e.g., cervical\n                  cancer in situ.\n\n          -  Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy,\n             endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal\n             antibodies, other investigational agent) within14 days prior to the first dose of\n             study drug (14 days prior to the first dose of study drug for subjects who have\n             received prior TKIs [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for\n             nitrosourea or mitomycin C).\n\n          -  Mean QT interval corrected for heart rate (QTc) ?470 ms on electrocardiogram (ECG)\n             using Frediricia's Correction.\n\n          -  Current or prior use of immunosuppressive medication within 28 days before the first\n             dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or\n             systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of\n             prednisone, or an equivalent corticosteroid.\n\n          -  Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy. (Subjects\n             with irreversible toxicity that is not reasonably expected to be exacerbated by the\n             investigational product may be included (e.g., hearing loss, peripheral neuropathy).\n\n          -  Any prior Grade ?3 Immune-mediated adverse event (imAE) while receiving any previous\n             immunotherapy agent, or any unresolved imAE >Grade 1.\n\n          -  Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects\n             with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within\n             the past 2 years) are not excluded. Patients with h/o completely resolved childhood\n             asthma or atopy will not be excluded. Patients with well-controlled hypothyroidism on\n             thyroxine replacement will be eligible as well.\n\n          -  Active or prior documented inflammatory bowel disease (e.g., Crohn's disease,\n             ulcerative colitis).\n\n          -  History of and/or confirmed pneumonitis.\n\n          -  History of primary immunodeficiency.\n\n          -  History of allogeneic organ transplant.\n\n          -  History of hypersensitivity to durvalumab or any excipient.\n\n          -  History of hypersensitivity to the combination or radiation therapy.\n\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\n             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable\n             angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active\n             bleeding diatheses including any subject known to have evidence of acute or chronic\n             hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric\n             illness/social situations that would limit compliance with study requirements or\n             compromise the ability of the subject to give written informed consent.\n\n          -  Known history of previous clinical diagnosis of tuberculosis.\n\n          -  Receipt of live attenuated vaccination within 30 days prior to study entry or within\n             30 days of starting treatment with durvalumab.\n\n        Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and\n        are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated\n        vaccines, and are not allowed.\n\n          -  Female subjects who are pregnant, breast-feeding or male or female patients of\n             reproductive potential who are not employing an effective method of birth control. For\n             this study male or female patients of reproductive potential need to employ two highly\n             effective and acceptable forms of contraception throughout their participation in the\n             study and for 90 days after last dose of study drug\n\n          -  Any condition that, in the opinion of the investigator, would interfere with\n             evaluation of study treatment or interpretation of patient safety or study results.\n\n          -  Brain metastases or history of leptomeningeal carcinomatosis.\n\n          -  Subjects with uncontrolled seizures.\n\n          -  Previous definitive radiation to pelvic area.Xx_NEWLINE_xXStable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatmentXx_NEWLINE_xXPrior treatment specifics:\r\n* Participants must have radiological or objective evidence of progression to a CDK4/6 inhibitor regimen in the metastatic setting AND relapse/progression on an nonsteroidal anti-inflammatory drug (NSAI) (defined as either relapsed =< 12 months after completing adjuvant NSAI or progressed through an NSAI for metastatic or locally advanced breast cancer)\r\n* Participants may have received any number of previous endocrine/hormonal lines of therapy in the metastatic setting, as long none of them were exemestane-based and the last dose is >= 14 days prior to registration\r\n* Participants may have received any CDK4/6 inhibitor (i.e. palbociclib, ribociclib, abemacicliclib, etc) as long as the last dose is >= 14 days prior to registration\r\n* Participants may have received up to one prior chemotherapy line for advanced breast cancer as long as the last dose is >= 21 days prior to registration\r\n* Participants may have received prior biologic treatments or investigational drugs as long as the last dose is >= 21 days prior to registration\r\n* Participants may have received radiotherapy for palliative purposes but must not be experiencing > grade 1 treatment related toxicities and have completed treatment >= 14 days prior to registrationXx_NEWLINE_xXSubject has received small molecule therapy, radiotherapy, immunotherapy, monoclonal antibodies, investigational drug, or chemotherapy within 14 days before first dose of study drug, with the exception of hydroxyureaXx_NEWLINE_xXNo prior other anti-cancer therapy, including ACT, for 28 days prior to study administration of atezolizumabXx_NEWLINE_xXGlycated hemoglobin (HbA1c) < 6.4%, within 14 days of registrationXx_NEWLINE_xXResolution or stabilization of clinically significant adverse events from prior therapy (completed at least 14 days prior to first dose of talimogene laherparepvec [TVEC])Xx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must satisfy the following criteria to be enrolled in the study:\n\n          1. Subject is ?18 years of age at the time of signing the informed consent form (ICF)\n\n          2. Subject must understand and voluntarily sign an ICF prior to any study-related\n             assessments/procedures being conducted\n\n          3. Subject is willing and able to adhere to the study visit schedule and other protocol\n             requirements\n\n          4. Subjects must have a documented diagnosis of Multiple myeloma (MM) and have measurable\n             disease by serum and/or urine protein electrophoresis (sPEP or uPEP): sPEP ?0.5 g/dL\n             or uPEP\n\n             ?200 mg/24 hours\n\n          5. All subjects must have received at least 2 prior myeloma regimens (note: induction\n             with or without bone marrow transplant and with or without maintenance therapy is\n             considered one regimen)\n\n          6. All subjects must have received prior treatment with at least 2 consecutive cycles of\n             a lenalidomide or pomalidomide-containing regimen\n\n          7. All subjects must have received prior treatment with at least 2 consecutive cycles of\n             a proteasome inhibitor or a proteasome inhibitor-containing regimen\n\n          8. For Part 2 (Cohort C and Cohort D), all subjects must have received prior treatment\n             with at least 2 consecutive cycles of an anti-CD38 therapy or an anti-CD38-containing\n             regimen\n\n          9. All subjects must have documented disease progression on or within 60 days from the\n             last dose of their last myeloma therapy\n\n         10. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2\n\n         11. A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at\n             some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has\n             not been naturally postmenopausal (amenorrhea following cancer therapy does not rule\n             out childbearing potential) for at least 24 consecutive months (ie, has not had menses\n             at any time in the preceding 24 consecutive months) and must:\n\n               1. Have two negative pregnancy tests as verified by the Investigator prior to\n                  starting study therapy. She must agree to ongoing pregnancy testing during the\n                  course of the study, and after end of study therapy. This applies even if the\n                  subject practices true abstinence* from heterosexual contact.\n\n               2. Either commit to true abstinence* from heterosexual contact (which must be\n                  reviewed on a monthly basis and source documented) or agree to use, and be able\n                  to comply with two forms of contraception: one highly effective, and one\n                  additional effective (barrier) measure of contraception without interruption 28\n                  days prior to starting investigational product, during the study therapy\n                  (including dose interruptions), and for 28 days after discontinuation of study\n                  therapy. Contraception requirements are detailed in Appendix D.\n\n         12. Male subjects must:\n\n             a. Practice true abstinence* (which must be reviewed on a monthly basis and source\n             documented) or agree to use a condom during sexual contact with a pregnant female or a\n             female of childbearing potential while participating in the study, during dose\n             interruptions and for at least 90 days following the last dose of CC-220, even if he\n             has undergone a successful vasectomy.\n\n             * True abstinence is acceptable when this is in line with the preferred and usual\n             lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation,\n             symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of\n             contraception.]\n\n         13. Males must agree to refrain from donating sperm while on CC-220, during dose\n             interruptions and for at least 90 days following last dose of CC-220.\n\n         14. All subjects must agree to refrain from donating blood while on CC-220, during dose\n             interruptions and for at least 28 days following the last dose of CC-220.\n\n         15. All male and female subjects must follow all requirements defined in the Pregnancy\n             Prevention Program (v5.1).\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment:\n\n          1. Subject has any significant medical condition, laboratory abnormality, or psychiatric\n             illness that would prevent the subject from participating in the study\n\n          2. Subject has any condition including the presence of laboratory abnormalities, which\n             places the subject at unacceptable risk if he/she were to participate in the study\n\n          3. Subject has any condition that confounds the ability to interpret data from the study\n\n          4. Subject has nonsecretory or oligosecretory multiple myeloma\n\n          5. Subjects with Plasma Cell leukemia\n\n          6. Any of the following laboratory abnormalities\n\n               -  Absolute neutrophil count (ANC) <1,000/?L\n\n               -  Platelet count <75,000/?L Corrected serum calcium >13.5 mg/dL (>3.4 mmol/L)\n\n               -  Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST)\n                  or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) ?2.0\n                  x upper limit of normal (ULN)\n\n               -  Serum total bilirubin and alkaline phosphatase >1.5 x Upper Limit of Normal (ULN)\n\n               -  Subjects with serious renal impairment (24-hour creatinine clearance [CrCl] <50\n                  mL/min) or requiring dialysis would be excluded\n\n          7. Subjects with peripheral neuropathy ?Grade 2\n\n          8. Subjects with gastrointestinal disease that may significantly alter the absorption of\n             CC-220\n\n          9. Subjects with a prior history of malignancies, other than MM, unless the subject has\n             been free of the disease for ?5 years with the exception of the following noninvasive\n             malignancies:\n\n               -  Basal cell carcinoma of the skin\n\n               -  Squamous cell carcinoma of the skin\n\n               -  Carcinoma in situ of the cervix\n\n               -  Carcinoma in situ of the breast\n\n               -  Incidental histological findings of prostate cancer such as T1a or T1b using the\n                  Tumor/Node/Metastasis (TNM) classification of malignant tumors or prostate cancer\n                  that is curative\n\n         10. Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide,\n             pomalidomide or DEX\n\n         11. Subject has known or suspected hypersensitivity to the excipients contained in the\n             formulation of CC-220 or DEX\n\n         12. Subject has received any of the following within the last 14 days of initiating IP:\n\n               -  Plasmapheresis\n\n               -  Major surgery (as defined by the Investigator)\n\n               -  Radiation therapy other than local therapy for MM associated bone lesions\n\n               -  Use of any systemic myeloma drug therapy\n\n         13. Subject has been treated with an investigational agent (ie, an agent not commercially\n             available) within 28 days or 5 half-lives (whichever is longer) of initiating\n             investigational product (IP)\n\n         14. Subject has any one of the following:\n\n               -  Clinically significant abnormal electrocardiogram (ECG) finding at Screening\n\n               -  Congestive heart failure (New York Heart Association Class III or IV)\n\n               -  Myocardial infarction within 12 months prior to starting IP\n\n               -  Unstable or poorly controlled angina pectoris, including the Prinzmetal variant\n                  of angina pectoris\n\n         15. Subject has current or prior use of immunosuppressive medication within 14 days prior\n             to the first dose of IP. The following are exceptions to this criterion:\n\n               -  Intranasal, inhaled, topical or local steroid injections (eg, intra-articular\n                  injection)\n\n               -  Systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of\n                  prednisone or equivalent\n\n               -  Steroids as premedication for hypersensitivity reactions (eg, computed tomography\n                  [CT] scan premedication)\n\n         16. Subject has taken a strong inhibitor or inducer of CYP3A4/5 including grapefruit, St.\n             John's Wort or related products within two weeks prior to dosing and during the course\n             of study\n\n         17. Subject known to test positive for human immunodeficiency virus (HIV), chronic or\n             active hepatitis B, or active hepatitis A or C\n\n         18. Subject is unable or unwilling to undergo protocol required thromboembolism\n             prophylaxis\n\n         19. Subject is a female who is pregnant, nursing or breastfeedingXx_NEWLINE_xXFor subjects on corticosteroids for endocrine deficiencies or tumor-associated symptoms, must be on a stable (or decreasing) dose for at least 7 days before first dose of study treatment.Xx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must meet all of the following criteria:\n\n          1. Written and signed informed consent.\n\n          2. Age ? 18 years at the time of study entry.\n\n          3. Subjects must have received and have progressed, are refractory, or are intolerant to\n             standard therapy appropriate for the specific tumor type. Subjects should not have\n             received more than 3 prior lines of systemic therapy for recurrent or metastatic.\n\n          4. Subjects in the dose-escalation phase, must have histologic documentation of advanced\n             solid tumors, excluding primary CNS tumors and hematologic malignancies.\n\n          5. Subjects in the dose-expansion phase, must have recurrent or metastatic disease solid\n             tumors according to treatment arm as specified in the protocol.\n\n          6. Subjects who have received prior therapy with regimens containing CTLA 4, PD L1, or PD\n             1 antagonists are permitted to enroll if additional protocol criteria are met.\n\n          7. Subjects must have at least 1 lesion that is measurable using RECIST guidelines.\n\n          8. Subjects must consent to provide archived tumor specimens for correlative biomarker\n             studies. In the setting where archival material is unavailable or unsuitable for use,\n             subjects must consent and undergo fresh tumor biopsy.\n\n          9. All subjects are encouraged to consent to and provide both pretreatment and on\n             treatment tumor biopsies.\n\n         10. ECOG Performance score of 0 or 1, unless protocol exceptions are met.\n\n         11. In the opinion of the investigator likely to complete ? 8 weeks of treatment.\n\n         12. Adequate hematologic, renal and hepatic function as determined by blood laboratory\n             values.\n\n         13. At the time of Day 1 of the study, subjects with CNS metastases must have been treated\n             and must be asymptomatic and meet the following:\n\n               1. No concurrent treatment, inclusive of, but not limited to surgery, radiation,\n                  and/or corticosteroids\n\n               2. At least 42 days without progression of CNS metastases as evidenced by magnetic\n                  resonance imaging (MRI) or computed tomography (CT) after last day of treatment\n\n               3. At least 14 days since last dose of corticosteroids Note: Subjects with\n                  leptomeningeal disease or cord compression are excluded from the study.\n\n         14. Female subjects of childbearing potential who are sexually active with a\n             non-sterilized male partner must use at least 1 highly effective method of\n             contraception from screening, and must agree to continue using such precautions for\n             180 days after the final dose of investigational product.\n\n         15. Non-sterilized male subjects who are sexually active with a female partner of\n             childbearing potential must use male condom plus, if locally available, spermicide\n             from Day 1 and for 180 days after receipt of the final dose of investigational\n             product.\n\n        Exclusion Criteria:\n\n        Any of the following would exclude the subject from participation in the study:\n\n          1. Prior treatment with TNFRSF agonists\n\n          2. Prior treatment with IMT for certain disease types may be restricted per protocol.\n\n          3. History of severe allergic reactions to any unknown allergens or any components of the\n             study drug formulations\n\n          4. Active or prior documented autoimmune disease within the past 2 years.\n\n          5. Concurrent enrollment in another clinical study, unless it is an observational\n             clinical study or the follow up period of an interventional study\n\n          6. Receipt of any conventional or investigational anticancer therapy not otherwise\n             specified above within 28 days prior to the first dose\n\n          7. Any concurrent chemotherapy, IMT, or biologic or hormonal therapy for cancer\n             treatment.\n\n          8. Unresolved toxicities from prior anticancer therapy.\n\n          9. Systemic therapeutic anticoagulation or daily aspirin dose exceeding 325 mg/per day.\n\n         10. Current or prior use of immunosuppressive medication within 14 days prior to the first\n             dose of MEDI0562 with exceptions as per protocol.\n\n         11. History of primary immunodeficiency, solid organ transplantation, or tuberculosis\n\n         12. Test results indicating active infection with human immunodeficiency virus (HIV) or\n             hepatitis B or C defined by positive serologic testing and confirmatory viral nucleic\n             acid testing\n\n         13. Pregnant or breastfeeding women\n\n         14. Major surgery within 4 weeks prior to first dose of MEDI0562 or still recovering from\n             prior surgery.\n\n         15. Other invasive malignancy within 2 years with the exception of protocol specified\n             criteria\n\n         16. Any uncontrolled intercurent illness or condition that, in the opinion of the\n             investigator, would interfere with evaluation of the investigational product or\n             interpretation of subject safety or study results.Xx_NEWLINE_xXRadiographically-confirmed progression of, or recurrent, primary or secondary Grade IV glioma, and must be on a stable or decreasing dose of steroid for at least five days prior to the date of informed consent.Xx_NEWLINE_xXPatient has had chemotherapy within 28 days prior to first administration of study drug.Xx_NEWLINE_xXPrior cytotoxic chemotherapy within 21 days from the initiation of HCT conditioning. Note, certain low intensity treatments not intended to induce remission but rather stabilize disease are acceptable up to 7 days prior to initiation of HCT conditioningXx_NEWLINE_xXRadiotherapy within 14 days before randomization; seven days may be considered if to single areaXx_NEWLINE_xXPrior radiation within 14 days before start of study registrationXx_NEWLINE_xXResting baseline oxygen saturation >= 92% at rest - by pulse oximetry, performed within 14 days of treatment initiationXx_NEWLINE_xXPatients who are on dexamethasone must be on a stable or decreasing dose for at least one week prior to registrationXx_NEWLINE_xXPatient must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent >= 7 days prior to study registration; for biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registrationXx_NEWLINE_xXPatient has received radiation therapy prior to study registration; patients must have had their last fraction of local irradiation to the primary tumor >= 3 months prior to registration, their last fraction of craniospinal irradiation (>= 24 Gy) or total body irradiation >= 3 months prior to registration or >= 6 weeks (wks) for the therapeutic doses of MIBG; patient has not received focal irradiation for symptomatic metastatic sites within 14 days prior to registrationXx_NEWLINE_xXUse of the following antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to the first dose of study treatment; or pegylated interferon in the 14 days before the first dose of study treatmentXx_NEWLINE_xXImmunomodulating agents <28 days prior to first dose of study drugXx_NEWLINE_xXUse of other investigational agents from 30 days prior to the Screening Visit through discontinuation of study drug.Xx_NEWLINE_xXSteroid treatment within seven (7) days prior to study treatment. Patients that require intermittent use of bronchodilators, topical steroids or local steroid injections will not be excluded from the study. Patients who have been stabilized to 10 mg PO QD or less seven (7) days prior to study drug administration are allowed.Xx_NEWLINE_xXWhole blood transfusion in the last 120 days prior to entry to the studyXx_NEWLINE_xXTreatment with any investigational products within 28 days prior to study registrationXx_NEWLINE_xXInitiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers) within 1 week prior to study registration (subjects already receiving erythropoietin on a chronic basis for >= 28 days are eligible)Xx_NEWLINE_xXSubjects requiring daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days prior to study registrationXx_NEWLINE_xXBiologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chairXx_NEWLINE_xXSubjects receiving corticosteroids must be on a stable or decreasing dose of corticosteroid for the prior 7 daysXx_NEWLINE_xXPatients who received any of the following within the 14 days before initiating study treatment:Xx_NEWLINE_xXPatients may not have received any other investigational agents within the last 14 days at the time of treatment startXx_NEWLINE_xXAny major surgery, chemotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed >= 2 weeks); concurrent hydroxyurea is allowed if less than or equal to 2 grams daily and on stable dose for >= 14 days prior to study entryXx_NEWLINE_xXPatient has received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) =< 28 days or limited field radiation for palliation =< 14 days prior to starting trial medications or has not recovered from side effects of such therapyXx_NEWLINE_xXPatients who have had radiotherapy within 14 days before registration are not eligible; NOTE: if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXProtocol treatment plan must include beginning therapy within 5 consecutive days after registrationXx_NEWLINE_xXUse of any other experimental medication(s) within 14 days prior to start of the study treatment.Xx_NEWLINE_xXThe following laboratory values obtained =< 21 days prior to registration; complete blood count (CBC), sodium, potassium, aspartate aminotransferase (AST), bilirubin and creatinine are to be obtained pre-study; Note: treatment initiation and dosing modification should be performed at the individual investigators discretion and be consistent with the product label and their medical practiceXx_NEWLINE_xXClinical MRIs performed at baseline must be completed within 28 days before the first dose of cabozantinibXx_NEWLINE_xXMust have the following laboratory values, obtained less than or equal to 7 days prior to registration:Xx_NEWLINE_xXPrior use of hormone contraceptives and replacement therapy is allowed (e.g., estrogen and/or progestin), but must have been discontinued at least 30 days prior to the study enrollment; vaginal preparations (e.g., Vagifem or Estring) are allowedXx_NEWLINE_xXUse of other investigational drugs at the time of screening or within the last 30 days.Xx_NEWLINE_xXMore than 1 month of prior hormone exposure or hormone exposure within 30 days of registration; prior enzalutamide, ketoconazole, abiraterone, or TAK700 prohibited; prior 5alpha-reductase inhibitors are allowedXx_NEWLINE_xXUse of a potent inhibitor or inducer of drug transporters or conjugating enzymes within 14 days prior to planned study treatment or expected requirement for use of such a drug during studyXx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of starting treatment with abataceptXx_NEWLINE_xXNew immunosuppressive medication or extracorporeal photochemotherapy (ECP) within 28 days of starting treatment with abataceptXx_NEWLINE_xXUse of corticosteroids (glucocorticoids) within 21 days of the MILs collectionXx_NEWLINE_xXPatients may not have had any prior systemic therapy =< 21 days prior to registration for treatment of ovarian cancerXx_NEWLINE_xXPatients who have received prior treatment for lymphoma are not eligible\r\n* NOTE: Patients may have received corticosteroids for lymphoma for 10 or fewer days at any dose (no washout period required)\r\n* NOTE: Patients may have received up to 1 prior dose of rituximab before registration; in this case, patients will only receive 3 doses of rituximab on studyXx_NEWLINE_xXPatients must not have ongoing treatment with any other investigational agents =< 14 days prior to registrationXx_NEWLINE_xXAll radiology studies (study requiring staging) must be performed within 35 days prior to the start of therapyXx_NEWLINE_xXMale pts cannot donate semen or sperm while taking pomalidomide and for 28 days after completing the study.Xx_NEWLINE_xXUse of any other experimental drug or therapy within 21 days prior to first doseXx_NEWLINE_xXExposure to any prior chemotherapy, steroid use, or other myeloma treatment within 14 days prior to first dose. Pts currently on long term steroids do not require any washout period. in addition, steroid use for spinal cord compression is permitted and does not require a washout period.Xx_NEWLINE_xXHistory/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.Xx_NEWLINE_xXAt least 14 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur; these patients must be discussed with the Study Chair or Co-Chair on a case-by-case basis including any patient on a drug with a half-life of > 48 hoursXx_NEWLINE_xXCompleted single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study or Continue to receive treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of the parent study closure if the participant received the last dose of control arm study drug within the 6 weeks (42 days) prior to the first dose of control arm study therapy in the extension studyXx_NEWLINE_xXTreatment with antibiotics within 14 days prior to first dose of study drug.Xx_NEWLINE_xXSubjects must have completed systemic therapy at least 28 days prior to first dose.Xx_NEWLINE_xXCurrent use, or up to 14 days prior use, of certain prohibited medication or requires any of these medications during treatment phase.Xx_NEWLINE_xX>10% weight loss over the 28 days prior to consent.Xx_NEWLINE_xXStable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatmentXx_NEWLINE_xXStable dose of dexamethasone 2 mg or less for at least 7 days prior to initiation of treatmentXx_NEWLINE_xXUnresolved or unstable, serious adverse events from prior administration of another investigational drug.Xx_NEWLINE_xXa radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drugXx_NEWLINE_xXTreatment with surgery or chemotherapy within 21 days prior to study entry (42 days for nitrosoureas or mitomycin C)Xx_NEWLINE_xXSubject receiving concurrent chemotherapeutics or investigational agents within 30 days of study entry, including gliadel wafers or gliasite application.Xx_NEWLINE_xXWithin 10 (except as noted) days of planned treatment initiation: Lactate dehydrogenase (LDH) =< 1.5 x institutional ULN (may be within 28 days)Xx_NEWLINE_xXSubjects using agents known to inhibit or induce CYP3A4, such as ketoconazole, itraconazole, erythromycin, or rifampin, within 7 days prior to study startXx_NEWLINE_xXAvoid conceiving for at least 12 months after the last dose of rituximab, or according to the local rituximab Prescribing Information or Summary of Product characteristics (SmPC); at least 28 days after the last dose of any other study drug.Xx_NEWLINE_xXA serum TSH and AM cortisol must be obtained within 28 days prior to randomization to obtain a baseline value.Xx_NEWLINE_xXObtained within 14 days prior to C1D1: Neutrophils >= 1500/uLXx_NEWLINE_xXObtained within 14 days prior to C1D1: Oxygen saturation (O2 Sat.) >= 92% on ambient airXx_NEWLINE_xXObtained within 14 days prior to C1D1: HBV surface antibody positive or negativeXx_NEWLINE_xXObtained within 14 days prior to C1D1: HBV viral load negativeXx_NEWLINE_xXObtained within 14 days prior to C1D1: HCV NA analysis negativeXx_NEWLINE_xXInclusion Criteria:\n\n          -  Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no\n             limit to the number of prior treatment regimens) that is confirmed by available\n             pathology records or current biopsy as well as:\n\n               -  Subject in the escalation cohort has received all standard therapies (unless the\n                  therapy is contraindicated or intolerable) felt to provide clinical benefit for\n                  the subject's specific tumor type. OR\n\n               -  Subject in an expansion cohort has received at least one standard therapy for the\n                  subject's specific tumor type.\n\n          -  For Korea only: Subject has locally-advanced (unresectable) or metastatic solid tumor\n             malignancy (no limit to the number of prior treatment regimens) that is confirmed by\n             available pathology records or current biopsy and has received all standard therapies\n             (unless the therapy is contraindicated or intolerable) felt to provide clinical\n             benefit for the subject's specific tumor type.\n\n          -  Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or\n             2.\n\n          -  Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was\n             at least 21 days prior to initiation of study drug administration. A subject with\n             epidermal growth factor receptor (EGFR) mutation-positive NSCLC is allowed to remain\n             on EGFR tyrosine kinase inhibitor (TKI) therapy until 4 days prior to the start of\n             study drug administration.\n\n          -  For Korea only: Subject's last dose of prior antineoplastic therapy, including any\n             immunotherapy, was at least 21 days prior to initiation of study drug administration.\n             For drugs with a half-life greater than or equal to 21 days, the investigator should\n             consider if this washout is sufficient. A subject with epidermal growth factor\n             receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) is allowed to\n             remain on EGFR tyrosine kinase inhibitor (TKI) therapy until 7 days prior to the start\n             of study drug administration.\n\n          -  Subject has completed any radiotherapy (including stereotactic radiosurgery) at least\n             2 weeks prior to study drug administration.\n\n          -  Subject's adverse events (excluding alopecia) from prior therapy have improved to\n             grade 1 or baseline within 14 days prior to start of study treatment.\n\n          -  Subject with metastatic castration resistant prostate cancer (mCRPC) (positive bone\n             scan and/or soft tissue disease documented by computed tomography (CT) / magnetic\n             resonance imaging (MRI)) meets both of the following:\n\n               -  Subject has serum testosterone ? 50 ng/dL at screening.\n\n               -  Subject has had an orchiectomy or plans to continue androgen deprivation therapy\n                  (ADT) for the duration of study treatment.\n\n          -  Subject has adequate organ function prior to start of study treatment as indicated by\n             the following laboratory values. If a subject has received a recent blood transfusion,\n             the laboratory tests must be obtained ? 4 weeks after any blood transfusion.\n\n          -  Female subject must either:\n\n               -  Be of non-childbearing potential: Postmenopausal (defined as at least 1 year\n                  without any menses for which there is no other obvious pathological or\n                  physiological cause) prior to screening, or documented surgically sterile (e.g.,\n                  hysterectomy, bilateral salpingectomy, bilateral oophorectomy).\n\n               -  Or, if of childbearing potential, agree not to try to become pregnant during the\n                  study treatment and for 6 months after the final study drug administration, and\n                  have a negative urine or serum pregnancy test prior to study drug administration,\n                  and, if heterosexually active, agree to consistently use one form of highly\n                  effective birth control starting at screening and throughout the study treatment\n                  and 6 months after the final study drug administration.\n\n          -  Female subject must agree not to breastfeed starting at screening and throughout the\n             study treatment, and for 6 months after the final study drug administration.\n\n          -  Female subject must not donate ova starting at screening and throughout the study\n             treatment, and for 6 months after the final study drug administration.\n\n          -  A sexually active male subject with female partner(s) who are of childbearing\n             potential is eligible if:\n\n               -  Agree to use a male condom starting at screening and continue throughout the\n                  study treatment, and for 6 months after the final study drug administration.\n\n               -  If the male subject has not had a vasectomy or is not sterile as defined below\n                  the subject female partner(s) is utilizing one form of highly effective birth\n                  control starting at screening and continue throughout the study treatment and for\n                  6 months after the final study drug administration.\n\n          -  Male subject must not donate sperm starting at screening and throughout the study\n             treatment, and for 6 months after the final study drug administration.\n\n          -  Male subject with a pregnant or breastfeeding partner(s) must agree to remain\n             abstinent or use a condom for the duration of the pregnancy or time partner is\n             breastfeeding throughout the study treatment and for 6 months after the final study\n             drug administration.\n\n          -  Subject agrees not to participate in another interventional study while receiving\n             study drug (subjects who are currently in the follow-up period of an interventional\n             clinical trial are allowed).\n\n        Additional Inclusion Criteria for Subjects in the Expansion Cohorts:\n\n          -  Subject meets one of the following:\n\n               -  Subject has the tumor type for which a confirmed response was observed in a\n                  monotherapy or combination therapy dose escalation cohort; or\n\n               -  For an expansion cohort opened due to achieving predicted efficacious exposure,\n                  subject has squamous cell carcinoma of the head and neck (SCCHN).\n\n          -  Subject has at least 1 measureable lesion per Response Evaluation Criteria in Solid\n             Tumors (RECIST) 1.1. The measureable lesion must be outside the field of radiation if\n             subject had prior radiotherapy. Subjects with mCRPC who do not have measurable lesions\n             must have at least one of the following:\n\n               -  Progression with 2 or more new bone lesions; or\n\n               -  Prostate-specific antigen (PSA) progression (defined as a minimum of three rising\n                  PSA levels with an interval of ? 1 week between each determination) within 6\n                  weeks prior to study drug administration and a PSA value at the screening visit ?\n                  2 ng/mL.\n\n          -  Subject consents to provide an available tumor specimen in a tissue block or unstained\n             serial slides obtained within 56 days prior to first dose of study treatment, or\n             subject is an appropriate candidate for tumor biopsy and is amenable to undergoing a\n             tumor biopsy (core needle biopsy or excision) during the screening period.\n\n          -  Subject in a SCCHN monotherapy or combination therapy expansion cohort, is an\n             appropriate candidate for tumor biopsy and consents to undergoing a tumor biopsy (core\n             needle biopsy or excision) during the treatment period as indicated in the Schedule of\n             Assessments.\n\n        Exclusion:\n\n          -  Subject weighs < 45 kg at screening.\n\n          -  Subject has received investigational therapy (other than an investigational epidermal\n             growth factor receptor tyrosine kinase inhibitor (EGFR TKI) in a subject with EGFR\n             activating mutations) within 21 days prior to start of study drug.\n\n          -  Subject requires or has received systemic steroid therapy or any other\n             immunosuppressive therapy within 14 days prior to study drug administration. Subjects\n             using a physiologic replacement dose of hydrocortisone or its equivalent (defined as\n             up to 30 mg per day of hydrocortisone up to 10 mg per day of prednisone) are allowed.\n\n          -  Subject has symptomatic central nervous system (CNS) metastases or subject has\n             evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans).\n             Subjects with previously treated CNS metastases are eligible, if subject is clinically\n             stable and have no evidence of CNS progression by imaging for at least 4 weeks prior\n             to start of study treatment and are not requiring immunosuppressive doses of systemic\n             steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or\n             equivalent) for longer than 2 weeks.\n\n          -  Subject has an active autoimmune disease. Subjects with type 1 diabetes mellitus,\n             endocrinopathies stably maintained on appropriate replacement therapy, or skin\n             disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment\n             are allowed.\n\n          -  Subject was discontinued from prior immunomodulatory therapy due to a grade ? 3\n             toxicity that was mechanistically related (e.g., immune related) to the agent.\n\n          -  Subject has known history of serious hypersensitivity reaction to a known ingredient\n             of ASP8374 or pembrolizumab or severe hypersensitivity reaction to treatment with\n             another monoclonal antibody.\n\n          -  Subject has a known history of Human Immunodeficiency Virus.\n\n          -  Subject with positive for Hepatitis B virus (HBV) antibodies and surface antigen\n             (including acute HBV or chronic HBV) or Hepatitis C ([HCV]; ribonucleic acid [RNA]\n             detected by qualitative assay). Hepatitis C RNA testing is not required in subjects\n             with negative Hepatitis C antibody testing.\n\n          -  Subject has received a live vaccine against infectious diseases within 28 days prior\n             to initiation of study treatment.\n\n          -  Subject has a history of drug-induced pneumonitis (interstitial lung disease) or\n             currently has pneumonitis.\n\n          -  Subject has an infection requiring systemic therapy within 14 days prior to study drug\n             treatment.\n\n          -  Subject has received a prior allogeneic bone marrow or solid organ transplant.\n\n          -  Subject is expected to require another form of antineoplastic therapy while on study\n             treatment.\n\n          -  Subject has had a myocardial infarction or unstable angina within 6 months prior to\n             the start of study treatment or currently has an uncontrolled illness including, but\n             not limited to symptomatic congestive heart failure, clinically significant cardiac\n             disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social\n             situations that would limit compliance with study requirements.\n\n          -  Any condition that makes the subject unsuitable for study participation.\n\n          -  Subject has had a major surgical procedure and has not completely recovered within 28\n             days prior to the start of study treatment.Xx_NEWLINE_xXCompletion of ASCT within 100 days prior to Day 1 of Cycle1.Xx_NEWLINE_xXExposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 28 days before the first dose of the IMP. Hormonal therapy may be administered up to 7 days prior to the first dose of the IMP.Xx_NEWLINE_xXClinically significant surgical intervention within 21 days of the first dose of the IMP or with ongoing post-operative complications if more than 21 days.Xx_NEWLINE_xXParticipant has had prior antineoplastic therapy within 14 days prior to starting study drug.Xx_NEWLINE_xXAre using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.Xx_NEWLINE_xXPatients taking PDE5 inhibitors more than 1/week during the previous 28 daysXx_NEWLINE_xXSubjects who are able and willing to give written informed consent\n\n          -  Documented primary or secondary AML, as defined by the WHO criteria (2008), by\n             histopathology refractory to previous induction chemotherapy and/or relapsed after\n             achieving remission with a prior chemotherapy and who are not candidates for other\n             available therapy likely to confer clinical benefit.\n\n          -  For Phase 2a only: in addition to inclusion criteria 2 above, patients must have a\n             FLT3 mutation of any type\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n\n          -  In the absence of rapidly progressing disease, the interval from prior treatment to\n             time of FF-10101-01 administration should be at least 14 days for cytotoxic agents\n             other than hydroxyurea, at least 5 half-lives for non-cytotoxic agents, and 14 days\n             for monoclonal antibody therapies. Hydroxyurea may be continued for a maximum of 14\n             days from the start of FF-10101-01 dosing, through Cycle 1 Day 14, with a maximal dose\n             of 5 grams/day\n\n          -  Persistent chronic clinically significant toxicities from prior chemotherapy or\n             surgery must be ?Grade 2\n\n          -  If subject has had a hematopoietic stem cell transplant, subject must be ?60 days\n             post-transplant with no clinically significant GVHD requiring systemic therapy\n\n          -  Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ?3 times the\n             upper limit of normal and total bilirubin of ?1.5x the upper limit of normal. If total\n             bilirubin is equal to or exceeds 1.5x the upper limit of normal, the subject can still\n             be included if direct bilirubin is ?1.5x the upper limit of normal\n\n          -  Calculated creatinine clearance of ?60 mL/min\n\n          -  Female subjects of childbearing potential and sexually mature male subjects must agree\n             to use a medically accepted method of contraception other than an oral contraceptive\n             for the duration of the study.\n\n        Exclusion Criteria:\n\n          -  Subjects diagnosed with acute promyelocytic leukemia\n\n          -  Subjects with Bcr-Abl positive leukemia (chronic myelogenous leukemia in blast crisis)\n\n          -  Subjects with clinically active CNS leukemia\n\n          -  Subjects with major surgery within 28 days prior to the first administration of\n             FF-10101-01\n\n          -  Subjects with radiation therapy within 28 days prior to the first administration of\n             FF-10101-01\n\n          -  Subjects with active malignant disease requiring therapy other than AML or\n             myelodysplastic syndrome with transformation into AML\n\n          -  Subjects with an active uncontrolled infection\n\n          -  Subjects with a medical condition, serious intercurrent illness, or other circumstance\n             that, in the Investigator's judgment, could jeopardize the subject's safety as a study\n             subject, or that could interfere with the study objectives\n\n          -  Subjects known to have human immunodeficiency virus infection, or who have active\n             hepatitis B or C infection as determined by serological testing\n\n          -  Subjects with congestive heart failure, New York Heart Association (NYHA) Class 3 or\n             4, or subjects with a past history of congestive heart failure NYHA Class 3 or 4 and\n             in whom echocardiogram or multiple gate acquisition (MUGA) scan performed within 3\n             months prior to screening or at screening showed a LVEF <40%\n\n          -  Female subjects who are pregnant or breast feeding\n\n          -  Subjects on 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) or\n             other drugs known to have muscle toxicity\n\n          -  Subjects taking strong inhibitors of CYP3A4 will be excluded from the study unless\n             therapeutic substitution is possible\n\n          -  Subjects taking strong inducers of CYP3A4 will be excluded from the study unless\n             therapeutic substitution is possible\n\n          -  Use of systemic immunosuppressive agents within 14 days prior to first dose of\n             FF-10101\n\n          -  Subjects taking drugs known to cause Torsades de Pointes will be excluded from the\n             study unless therapeutic substitution is possible\n\n          -  Subjects known to have long QT syndrome\n\n          -  Subjects with mean QTcF values following 3 ECGs conducted 5 minutes apart of >470 msecXx_NEWLINE_xXSteroid regimen stable or decreasing for at least 7 days prior to inoculationXx_NEWLINE_xXObtained within 28 days prior to registration: Bilirubin < 2.0 X ULNXx_NEWLINE_xXBaseline tumor measurements must be documented from tests within 28 days of study entry; other non-laboratory tests must be performed within 28 days of study entryXx_NEWLINE_xXLaboratory tests required for eligibility must be completed within 14 days prior study entry; baseline tumor measurements must be documented from tests within 28 days of study entry; other non-laboratory tests must be performed within 28 days of study entryXx_NEWLINE_xXInclusion Criteria:\n\n        Subjects are eligible to be included in the study only if they meet all of the following\n        criteria:\n\n          1. Subjects who are males or females ? 18 years of age.\n\n          2. Subjects who are able to give written informed consent.\n\n          3. Subjects who have a documented diagnosis of MDS according to WHO criteria.\n\n          4. Subjects who have Revised International Prognostic Scoring System (IPSS-R) categories\n             of Very Low, Low- or Intermediate-risk disease. Subjects with cytogenetic failure and\n             ? 10% marrow blasts will be eligible.\n\n          5. Subjects who meet one of the following hematologic criteria within 8 weeks of\n             registration (according to the IWG criteria) and as documented in prior transfusion\n             logs or weekly hematology evaluations:\n\n               -  Symptomatic anemia untransfused with hemoglobin ? 9.0 g/dL or with RBC\n                  transfusion-dependence (i.e., ? 2 units/month) confirmed for a minimum of 8 weeks\n                  before randomization.\n\n               -  Platelet counts of < 100 x109/L\n\n               -  Absolute neutrophil count < 1500\n\n          6. Subjects with del(5q) who should have failed or not be a candidate for approved\n             therapy (Lenalidomide) prior to enrolling on this study.\n\n          7. Subjects must meet accepted standard criteria for treatment and have failed or not be\n             candidates for standard, accepted treatments.\n\n          8. Subjects who have sufficient hepatic function, defined as bilirubin 2 times the upper\n             limit of normal (ULN) and alanine transaminase (ALT) and aspartate transaminase (AST)\n             levels 2.5 times ULN.\n\n          9. Subjects who have sufficient renal function, defined as serum creatinine levels 1.5\n             ULN.\n\n         10. Subjects who have a performance status of 2 on the Eastern Cooperative Oncology Group\n             (ECOG) scale (refer to Appendix 2).\n\n         11. Subjects who have discontinued all previous therapies for MDS or other investigational\n             therapy for at least 28 days prior to study enrollment and recovered to less than\n             grade 2 toxicity from prior therapy.\n\n         12. Subjects who are able to swallow tablets.\n\n         13. Subject who are willing and able to comply with scheduled visits, treatment plans,\n             laboratory tests and procedures.\n\n         14. Female subjects of childbearing potential must have a negative serum pregnancy test\n             within 7 days of the first administration of study drug. For the purpose of this\n             study, female subjects of childbearing potential are defined as all female subjects\n             after puberty unless they are postmenopausal for at least 1 year, or are surgically\n             sterile (hysterectomy or bilateral oophorectomy or tubal ligation).\n\n         15. Female subjects of child bearing potential who are willing to avoid the pregnancy\n             during the duration of the study and for 30 days following the last dose of study\n             drug. The effects of TEW-7197 on the developing human fetus are unknown. For this\n             reason, women of child-bearing potential and men must agree to use adequate\n             contraception (hormonal or barrier method of birth control; abstinence) prior to study\n             entry and for the duration of study participation. Should a woman become pregnant or\n             suspect she is pregnant while participating in this study, she should inform her\n             treating physician immediately.\n\n         16. Subjects with QTc interval calculated according to Fridericia's formula (QTcF =\n             QT/RR0.33; RR = RR interval) of ? 470 ms for males and 450 ms for females on screening\n             electrocardiogram (ECG).\n\n         17. Subjects must have ejection fraction more than 50% and no clinically significant\n             valvular dysfunction.\n\n         18. Subjects must have discontinued radiotherapy at least 14 days with resolution of any\n             toxicity to Grade 1 or better prior to the start of treatment.\n\n        Exclusion Criteria:\n\n        Subjects will be excluded from the study if they meet any of the following criteria:\n\n          1. Subjects who have received treatment within the last 28 days with a drug that has not\n             received regulatory approval for any indication at the time of study entry.\n\n          2. Subjects who have moderate or severe cardiac disease:\n\n          3. Subjects who have the presence of cardiac disease, including a myocardial infarction\n             within 6 months prior to study entry, unstable angina pectoris, New York Heart\n             Association (NYHA) Class III/IV congestive heart failure, or uncontrolled\n             hypertension.\n\n          4. Subjects who have documented major electrocardiogram (ECG) abnormalities at the\n             investigator's discretion (for example, symptomatic or sustained atrial or ventricular\n             arrhythmias, second- or third-degree atrioventricular block, bundle branch blocks,\n             ventricular hypertrophy, or recent myocardial infarction).\n\n          5. Subjects who have major abnormalities documented by echocardiography with Doppler (for\n             example, moderate or severe heart valve function defect and/or left ventricular\n             ejection fraction (LVEF) <50%, evaluation based on the institutional lower limit of\n             normal).\n\n          6. Subjects who have predisposing conditions that are consistent with development of\n             aneurysms of the ascending aorta or aortic stress (for example, family history of\n             aneurysms, Marfan-Syndrome, bicuspid aortic valve, evidence of damage to the large\n             vessels of the heart documented by CT scan with contrast).\n\n          7. Subjects who have documented iron, B12, folate deficiency as determined by the\n             investigator.\n\n          8. Female subjects who are breastfeeding, or intend to breastfeed during the duration of\n             the study and for 30 days following the last dose of study drug.\n\n          9. Subjects with any other serious medical condition which in the Investigator's opinion\n             would preclude safe participation in the study.\n\n         10. Subjects, in the opinion of the Investigator, who are unsuitable to participate in the\n             study.\n\n         11. Subjects with elevated Troponin 1 levels at screening or known to have persistently\n             elevated brain natriuretic peptide (BNP).\n\n         12. Subjects with serious pre-existing medical conditions as follows:\n\n               -  History of cardiac or aortic surgery,\n\n               -  Hypertension that is not controlled by standard medication (to 150/90 mmHg or\n                  below),\n\n               -  Cirrhosis of the liver, Child-Pugh Stage B or C, or history of liver transplant,\n\n               -  Severe diabetes that is not currently controlled,\n\n               -  Current or history of interstitial pneumonitis,\n\n               -  Presence of aneurisms of the ascending aorta or aortic stress.\n\n         13. Subjects with known history of difficulty swallowing, malabsorption or other\n             conditions that may reduce absorption of the product.\n\n         14. Subjects with major abnormalities identified by ECG or echocardiogram (ECHO), at the\n             Investigator's discretion.\n\n         15. Subjects with active infection with human immunodeficiency virus, hepatitis B virus or\n             hepatitis C virus.\n\n         16. Subjects with active infection requiring systemic antibiotic therapy.\n\n         17. Subjects who are currently using or planning to use:\n\n        Drugs which are exclusively or primarily eliminated by cytochrome P-450 isozyme 3A4Xx_NEWLINE_xXCreatinine =< 1.5 X institutional ULN, completed within 14 days prior to the date of registration ORXx_NEWLINE_xXFemale subject must agree not to breastfeed at screening and throughout the study period and for 45 days after the final study drug administration. Female subject must not donate ova starting at screening and throughout the study period and for 45 days after the final study drug administration.Xx_NEWLINE_xXMale subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.Xx_NEWLINE_xXRecent (within 30 days before enrollment) or concurrent yellow fever vaccinationXx_NEWLINE_xXConcurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib.Xx_NEWLINE_xXConcurrent use of CYP3A substrates with narrow therapeutic indices within 12 days prior to the first dose of lorlatinib or crizotinib.Xx_NEWLINE_xXFever within 3 days prior to study enrollment.Xx_NEWLINE_xXPatients must have discontinued all biologic therapy at least 21 days before participationXx_NEWLINE_xXPhase II only: Subjects must have presence of peripheral blood levels of IgG anti-?-glucan antibody (ABA) of ? 20 ?g/mL as determined by an ELISA test within 90 days prior to study registration.Xx_NEWLINE_xXAdequate coagulation functioning within 28 days prior to study registration defined by either of the following criteria:Xx_NEWLINE_xXMust have a pertinent history/physical examination within 90 days prior to registrationXx_NEWLINE_xXAt least 7 days must have elapsed since the completion of therapy with a biologic agent. For biologic agents that have known adverse events occurring beyond 7 days after administration, the period prior to enrollment must be extended beyond the time during which adverse events are known to occur.Xx_NEWLINE_xXAt least 21 days must have elapsed since the completion of the last dose of VEGF-Trap, and at least 7 days since a VEGF blocking tyrosine kinase inhibitor. Subjects must have recovered from any VEGF blocking drug-related toxicity (e.g., proteinuria).Xx_NEWLINE_xXPatients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible.Xx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular Therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation Therapy (XRT)/External Beam Irradiation including Protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapyXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy\r\n* Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody\r\n* Radiation therapy (XRT): at least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Stem cell infusion without TBI: no evidence of active graft vs host disease and at least 84 days must have elapsed after transplant or stem cell infusion\r\n* Patients must not have received prior exposure to ramucirumabXx_NEWLINE_xXEligible to receive induction chemotherapy, such as 7-10 days of cytosine arabinoside plus 2-3 days of an anthracycline, or high-dose cytarabineXx_NEWLINE_xXPatients must not receive metformin for at least 5 days prior to enrollment and for the duration of study treatmentXx_NEWLINE_xXUse of an investigational small molecule drug during the 30 days prior to screening or use of an investigational oligonucleotide or biologic drug during the prior 90 daysXx_NEWLINE_xXTreatment must be scheduled to commence within 14 working days after registration and may not begin prior to registration.Xx_NEWLINE_xXPlatelets >= 100,000/ mm^3 (unsupported) and documented within 14 days prior to registration and within 14 days prior to the start of treatmentXx_NEWLINE_xXAlbumin >= 2 g/dL and documented within 14 days prior to registration and within 14 days prior to the start of treatmentXx_NEWLINE_xXSerum creatinine =< 1.5 times upper limit of institutional normal for age, or and documented within 14 days prior to registration and within 14 days prior to the start of treatmentXx_NEWLINE_xXLab values must also be verified, meeting eligibility criteria, within 14 days prior to starting treatment. If treatment is planned > 14 days after lab values were obtained for registration, labs must be repeatedXx_NEWLINE_xXPrior treatment:\r\n* Patients may have received prior radiation therapy to index lesions >= 28 days prior to registration on this protocol if there has been documented progression by RECIST criteria; prior radiation therapy to the non-index lesions is allowed if >= 28 days prior to registration on this protocol\r\n* Prior RAI therapy is allowed if >= 90 days prior to registration on this protocol and evidence of progression (as defined above) has been documented in the interim (a diagnostic study using < 10 mCi of RAI is not considered RAI therapy)\r\n* Prior chemotherapy is allowed if >= 28 days prior to registration on this protocol\r\n* Patient may have received any number of prior lines of therapy\r\n* No prior use of sorafenib or an mammalian target of rapamycin (mTOR) (including phosphoinositide 3-kinase [PI3k] or protein kinase B [AKT]) inhibitor for the treatment of thyroid cancerXx_NEWLINE_xXUnintentional weight loss > 10% within 30 days prior to registrationXx_NEWLINE_xXBiologic agent: patient must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent >= 7 days prior to study registration\r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval should be discussed with the study chair\r\n* For biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registrationXx_NEWLINE_xXMonoclonal antibody treatment: at least three half-lives must have elapsed prior to registration; such patients should be discussed with the study chair prior to registration; for bevacizumab, patients must have received last dose >= 32 days prior to study registrationXx_NEWLINE_xXDocumented within 14 days of registration: Sodium: >= 130 and =< 145 mmol/LXx_NEWLINE_xXDocumented within 14 days of registration: Calcium: >= 7 mg/dLXx_NEWLINE_xXDocumented within 14 days of registration: Magnesium: >= 0.7 mmol/LXx_NEWLINE_xXPatient has adequate biological parameters as demonstrated by the following blood counts at baseline (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization):Xx_NEWLINE_xXPatient has the following blood chemistry levels at baseline (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization):Xx_NEWLINE_xXPatient not on anticoagulation has acceptable coagulation studies (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) below or within normal limits (+15%). Patients on anticoagulation must have coagulation values within the therapeutic range appropriate for the anti-coagulation indication.Xx_NEWLINE_xXPatient has no clinically significant abnormalities on urinalysis results (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization).Xx_NEWLINE_xXBaseline laboratory evaluations must be done within 14 days prior to randomization and some must be repeated < 72 hours prior to randomization.Xx_NEWLINE_xXAppropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination within 28 days prior to registration\r\n* Radiographic imaging of the chest, abdomen and pelvis within 28 days prior to registration documenting disease consistent with FIGO stage III or IV disease\r\n* Further protocol-specific assessmentsXx_NEWLINE_xXTreatment with an experimental therapy within the last 28 daysXx_NEWLINE_xXMale participants must not donate sperm throughout the study drug treatment period and for 127 days after the final study drug administration.Xx_NEWLINE_xXParticipant is ? 30 days and ? 90 days from hematopoietic cell infusion.Xx_NEWLINE_xXPatients who have received radiation within 14 days before the first dose of study treatmentXx_NEWLINE_xXAgree not to donate sperm during the course of this study or within 120 days after receiving their last dose of the study drugs.Xx_NEWLINE_xXDaily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of the study drugs.Xx_NEWLINE_xXPatients must not have received treatment with any chemotherapy, immunotherapy, radiotherapy or an investigational agent for malignancy within the 28 days preceding study registration; patients may not have received treatment with nitrosoureas or mitomycin within the 42 days prior to study registration; patients may not have received treatment with a small molecule targeted agent (including off-label or investigational use) within 14 days preceding study registration, provided this represents at least 7 half-lives for that agent; toxic effects from any prior therapy (except alopecia) must have resolved to grade 1 or less according to National Cancer Institute (NCI) CTCAE version (v)4.0 or to the patient’s baseline by the time of registrationXx_NEWLINE_xXRandomization within 28 days of diagnosis of last progressionXx_NEWLINE_xXConcurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 20 mg/day of prednisone) within 28 days of the first dose of study drugXx_NEWLINE_xXRecent infection requiring systemic treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXUse of drugs that might pose a risk of a drug-drug interaction within 2-7 days before the start of study therapy.Xx_NEWLINE_xXParticipant is able to complete a minimum of 14 days of study agent dosing prior to initiation of definitive treatment for their cancerXx_NEWLINE_xXParticipant is scheduled for an end of study biopsy within 22 days of starting study agent and within 36 days of their study screening visit; (if the participant is scheduled for surgical excision of the tumor and the surgery is delayed for any reason after the participant has started taking the study agent, study agent dosing may be extended up to a maximum of 25 days without compromising the evaluability of the end of study biomarkers)Xx_NEWLINE_xXObtained =< 21 days prior to registration and confirmed prior to the first dose of study drug: Platelets (PLT) >= 75,000/uL; platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollmentXx_NEWLINE_xXTreatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 halflives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administrationXx_NEWLINE_xXREGISTRATIONXx_NEWLINE_xXAgree to use condoms until 30 days following the last dose of investigational product, orXx_NEWLINE_xXHas had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study.Xx_NEWLINE_xXNeurological stability for at least 14 days prior to first dose of study drug;Xx_NEWLINE_xXFor patients with HGG and receiving glucocorticoid therapy, must be on stable or decreasing equivalent daily dose of glucocorticoids for 2 weeks (14 days) prior to dose assignmentXx_NEWLINE_xXPatients must have at least 14 days to recover from all prior treatment, including surgery, chemotherapy, immunotherapies, prior to enrollment on this protocolXx_NEWLINE_xXPatients may not receive any other anti-cancer therapies, within 28 days prior to registration and throughout the duration of this trialXx_NEWLINE_xXPatients with history of hematemesis or hemoptysis (defined as having bright red blood of 1/2 teaspoon or more per episode) within 28 days prior to registrationXx_NEWLINE_xXConcurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 20 mg/day of prednisone) within 28 days of the first dose of study drugXx_NEWLINE_xXRecent infection requiring systemic treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXSome protocol specified treatments prior to the first dose of study drug.Xx_NEWLINE_xXUse of other investigational drugs within 28 days prior to study drug administrationXx_NEWLINE_xX?28 days for a prior immunotherapy. No prior therapy with check point inhibitors, costimulatory agonists or immunomodulatory agents is allowed.Xx_NEWLINE_xX?28 days for prior systemic corticosteroid therapy.Xx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must meet all of the following applicable inclusion criteria to participate in\n        this study:\n\n          -  Male or female ? 18 years of age at time of consent. NOTE: Both pre- and\n             post-menopausal women are eligible. Pre-menopausal status is defined as either:\n\n               -  Last menstrual period within the last 12 months.\n\n               -  In case of therapy-induced amenorrhea, plasma estradiol and /or FSH is in the\n                  premenopausal range per local normal range.\n\n          -  Locally advanced, locoregionally recurrent, or metastatic disease, not amenable to\n             curative therapy. NOTE: Although not required as a protocol procedure, a patient with\n             a new metastatic lesion should be considered for biopsy whenever possible to reassess\n             ER/PR/HER2 status if clinically indicated. If a biopsy is prospectively done as part\n             of standard of care, the study would like to store samples for correlative research.\n\n          -  Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR\n             positive (ER >1%, PR >1%), HER2 negative breast cancer. NOTE: Subject has\n             HER2-negative breast cancer (based on most recently analyzed biopsy) is defined as a\n             negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a\n             negative in situ hybridization (e.g. FISH, CISH, SISH, DISH, etc.) test is required by\n             local laboratory testing.\n\n          -  Metastatic disease evaluable on imaging studies. Subjects may have measurable disease\n             as per RECIST 1.1 or bone-only disease. NOTE: Bone-only subjects are eligible if their\n             disease can be documented/ evaluated by bone scans, CT or MRI. Their disease will be\n             assessed using MDA criteria. NOTE: Previously irradiated lesions are eligible as a\n             target lesion only if there is documented progression of the lesion after irradiation.\n\n          -  No prior systemic anti-cancer therapy for advanced HR+ disease. NOTE: Subjects\n             receiving adjuvant treatment with aromatase inhibitors at time of recurrence are\n             allowed to participate. There is no AI washout period required.\n\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n\n          -  Provided written informed consent and Health Insurance Portability and Accountability\n             Act of 1996 (HIPAA) authorization for release of personal health information, approved\n             by an Institutional Review Board/Independent Ethics Committee (IRB/IEC). NOTE: HIPAA\n             authorization may be included in the informed consent or obtained separately.\n\n          -  Women of childbearing potential (WOCP) must not be pregnant or breast-feeding. A\n             negative serum or urine pregnancy test is required within 72 hours of study\n             registration from women of childbearing potential. If the urine test cannot be\n             confirmed as negative, a serum pregnancy test will be required.\n\n          -  Women of childbearing potential (WOCP) must be willing to use two effective methods of\n             birth control such as use of a double barrier method (condoms, sponge, diaphragm, or\n             vaginal ring with spermicidal jellies or cream), or total abstinence for the course of\n             the study until 120 days after the last dose of study drug. The use of hormonal\n             contraceptives is discouraged. NOTE: Women are considered to be of childbearing\n             potential unless they are postmenopausal for at least 12 consecutive months or\n             surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or\n             hysterectomy).\n\n          -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory\n             tests, and other study procedures.\n\n          -  Male subjects capable of fathering a child must agree to use adequate contraception or\n             total abstinence for the course of the study until 120 days after the last dose of the\n             study drug.\n\n        NOTE: Male subjects will be considered as capable of fathering a child unless they have\n        azoospermia (whether due to having had a vasectomy or due to an underlying medical\n        condition).\n\n          -  Co-enrollment in an imaging biomarker study or other non-therapeutic study is allowed.\n\n        Exclusion Criteria:\n\n        Subjects meeting any of the criteria below may not participate in the study:\n\n          -  Prior treatment with any CDK 4/6 inhibitor.\n\n          -  Confirmed diagnosis of HER2 positive disease.\n\n          -  Known uncontrolled or symptomatic CNS metastases. Subjects with known brain metastasis\n             will only be eligible after their tumors have been treated with definitive resection\n             and /or radiotherapy and they are neurologically stable for at least 1 month off\n             steroids.\n\n          -  Advanced, symptomatic, visceral spread with a life expectancy less than 4 months.\n\n          -  Prior (neo)adjuvant treatment with tamoxifen within the 12 months before study entry.\n\n          -  Prior history of blood clots, pulmonary embolism or deep vein thrombosis.\n\n          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly\n             alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled\n             nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n\n          -  Concurrent malignancy or malignancy within 3 years of randomization, with the\n             exception of adequately treated basal cell carcinoma, squamous cell skin carcinoma,\n             non-melanomatous skin cancer or curatively resected cervical cancer.\n\n          -  Any other concurrent severe and/or uncontrolled medical condition that would, in the\n             investigator's judgment, contraindicate subject participation in the clinical study.\n\n          -  Currently receiving any of the following substances and cannot be discontinued 7 days\n             prior to study registration:\n\n               -  Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit\n                  hybrids, pomelos, star-fruit, and Seville oranges.\n\n               -  Medications that have a narrow therapeutic window and are predominantly\n                  metabolized through CYP3A4/5.\n\n               -  Known strong inducers or inhibitors of CYP2D6.\n\n          -  Major surgery within 14 days prior to study registration or has not recovered from\n             major side effects of surgery.\n\n          -  Known history of human immunodeficiency virus [(HIV) HIV 1/2 antibodies].\n\n          -  Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA\n             [qualitative] is detected) (testing not mandatory)\n\n          -  Any clinically significant infection defined as any acute viral, bacterial, or fungal\n             infection that requires specific treatment. NOTE: Anti-infective treatment must be\n             completed ? 7 days prior to study registration.\n\n          -  Known allergy to palbociclib or any of its excipients\n\n          -  Presence of any non-healing wound, fracture, or ulcer within 28 days prior to study\n             registration. NOTE: if fracture is at a metastatic site, is chronic, and no surgical\n             treatment is planned, the subject can be enrolled.\n\n          -  Any condition that, in the opinion of the investigator, might jeopardize the safety of\n             the subject or interfere with protocol compliance.\n\n          -  Any mental or medical condition that prevents the subject from giving informed consent\n             or participating in the trial.\n\n          -  Treatment with any therapeutic investigational agent within 28 days prior to\n             registration for protocol therapy. The subject must have recovered from the acute\n             toxic effects of the regimen.Xx_NEWLINE_xXPRIOR TO STEP 1 REGISTRATIONXx_NEWLINE_xXPRIOR TO STEP 2 REGISTRATIONXx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXBiologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Study Chair.Xx_NEWLINE_xXAll herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of AMG 330Xx_NEWLINE_xXPrincipal Inclusion Criteria for All Patients\n\n          1. Male and female patients ? 18 years of age.\n\n          2. Any prior palliative radiation therapy must have been completed at least 7 days prior\n             to the start of study drugs, and patients must have recovered from any acute adverse\n             effects prior to the start of study treatment.\n\n          3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.\n\n          4. Baseline laboratory values within 7 days of study drug(s) initiation:\n\n             ANC ? 1500/?L Haemoglobin (Hgb) ?10 g/dL without transfusion in the past 28 days\n             Platelets ? 100,000/?L Alanine aminotransferase (ALT) and aspartate aminotransferase\n             (AST) ? 3 x ULN or ? 5 x ULN if known liver metastases.\n\n             Serum bilirubin within normal limits (WNL) or ?1.5 x ULN in patients with liver\n             metastases, or total bilirubin ?3.0 x ULN with direct bilirubin WNL in patients with\n             well-documented Gilbert's Syndrome.\n\n             Serum creatinine ?1.5 x ULN and creatinine clearance (CrCl) ? 51 mL/min\n\n          5. Female patients who are not of child-bearing potential, and fertile females of\n             childbearing potential who agree to use two highly effective forms of contraception in\n             combination from 2 weeks prior to study treatment and until 1 month after study\n             treatment discontinuation, are not breastfeeding, and must have a negative serum or\n             urine pregnancy test within 28 days of study treatment and confirmed prior to the\n             start of study treatment on first day of dosing.\n\n          6. Male patients should be willing to abstain or use barrier contraception (i.e., condoms\n             with a spermicide) for the duration of the study drug exposure and for 3 months after\n             study treatment discontinuation. Female partners of male patients should also use a\n             highly effective form of contraception if they are of childbearing potential, unless\n             the male patient is abstaining from sexual intercourse.\n\n          7. Predicted life expectancy ? 12 weeks. For patients in Part C the timing of this\n             assessment is applied from the beginning of Stage 2\n\n             Inclusion criteria specific to Part A\n\n          8. Histologically confirmed refractory solid tumour for which there is no known or\n             established treatment available with curative intent, after at least one course of\n             systemic therapy for locally advanced or metastatic disease including chemotherapy,\n             targeted therapy or hormonal therapy.\n\n          9. Measurable or non-measurable disease according to RECIST v1.1\n\n             Inclusion criteria specific to Part B\n\n         10. Relapsed small-cell lung cancer (SCLC) (defined as a histologically confirmed\n             diagnosis of SCLC) with advanced disease (recurrent or metastatic).\n\n         11. Patients must have a confirmed response (either PR or CR) to first-line platinum\n             therapy and then relapsed after completing that treatment. Patients who progressed\n             whilst on platinum-containing treatment (platinum refractory) are not permitted to\n             enter the study. Prior treatment with immunotherapy is permitted..\n\n         12. Has agreed to the collection of archival tumour tissue or recent tumor biopsy sample,\n             if taken for routine clinical purposes at baseline if archival tissue is not available\n             for molecular biomarker analyses.\n\n         13. Measurable disease according to RECIST v1.1 criteria.\n\n        Principal Exclusion Criteria\n\n          1. Prior treatment with a PARP inhibitor.\n\n          2. Use of an investigational drug during the past 30 days or 5 half-lives (whichever is\n             longer) prior to 1st dose of study treatment.\n\n          3. Use of anti-cancer treatment drug ? 21 days or 5 half-lives (whichever is shorter)\n             prior to 1st dose of study treatment. For drugs for which 5 half-lives is ? 21 days, a\n             minimum of 10 days between termination of the prior treatment and administration of\n             study treatment is required.\n\n          4. Radiotherapy (except for palliative reasons) within ? 21 days prior to study\n             treatment.\n\n          5. No other anti-cancer therapy (except for palliative local radiotherapy), biological\n             therapy, or other novel agent is permitted while the patient is receiving study\n             medication.\n\n          6. Major surgical procedures ? 28 days of beginning study treatment, or minor surgical\n             procedures ? 7 days. Patients must have recovered from any of the effects of any major\n             surgery. No waiting period required following port-a-cath placement.\n\n          7. Persistent Grade >1 toxicity from prior cancer therapy (except alopecia or anorexia).\n\n          8. Patient has an inability to swallow oral medications.\n\n          9. Known malignant central nervous system (CNS) disease other than neurologically stable,\n             treated brain metastases, defined as metastasis having no evidence of progression or\n             haemorrhage for at least 2 weeks after treatment. Must be off any systemic\n             corticosteroids for the treatment of brain metastases for at least 14 days prior to\n             enrolment.\n\n         10. Patient has had prescription or non-prescription drugs or other products known to be\n             sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index,\n             or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued\n             2 weeks prior to the olaparib PK sub-study dosing and withheld throughout the study\n             until 2 weeks after the last dose of study drug.\n\n         11. The use of sensitive substrates of CYP3A4, such as atorvastatin, simvastatin and\n             lovastatin are prohibited in this study. Co-administration of aprepitant or\n             fosaprepitant during this study is prohibited.\n\n         12. Herbal preparations are not allowed throughout the study, including but not limited\n             to: St. John's wort, kava, ephedra (ma hung), gingko biloba, dehydroepiandrosterone\n             (DHEA), yohimbe, saw palmetto and ginseng. Patients should stop using these herbal\n             medications 7 days prior to first dose of study treatment.\n\n         13. Any known hypersensitivity or contraindication to the components of the study drug\n             AZD1775 or olaparib.\n\n         14. Patients with either previous or current myelodysplastic syndrome/acute myeloid\n             leukaemia or features suggestive of MDS/AML.\n\n         15. Any of the following cardiac diseases currently or within the last 6 months as defined\n             by New York Heart Association (NYHA) ? Class 2.\n\n             Unstable angina pectoris Congestive heart failure Acute myocardial infarction\n             Conduction abnormality not controlled with pacemaker or medication Significant\n             ventricular or supraventricular arrhythmias (patients with chronic rate controlled\n             atrial fibrillation in the absence of other cardiac abnormalities are eligible)\n\n         16. AZD1775 should not be given to patients who have a history of Torsades des pointes\n             (TdP) unless all risk factors that contributed to TdP have been corrected.\n\n         17. Mean resting corrected QTc interval using the Fridericia formula [QTcF]) ? 470 msec\n             for female patients and ? 450 msec for male patients from 3 electrocardiograms (ECGs)\n             performed 2-5 minutes apart at study entry or congenital long QT syndrome. .\n\n         18. Pregnant or breastfeeding.\n\n         19. Serious known active infection at the time of enrolment, or another serious underlying\n             medical condition that would impair the ability of the patient to receive study\n             treatment.\n\n         20. Presence of other known active invasive cancers.\n\n         21. Psychological, familial, sociological, or geographical conditions that do not permit\n             compliance with protocol.\n\n         22. Patients considered a poor medical risk due to a serious, uncontrolled medical\n             disorder, non-malignant systemic disease or active, uncontrolled infection. Examples\n             include, but are not limited to, uncontrolled ventricular arrhythmia, recent (< 3\n             months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal\n             cord compression, superior vena cava syndrome, extensive interstitial bilateral lung\n             disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder\n             that prohibits obtaining informed consent.\n\n         23. Immunocompromised patients, e.g., patients who are known to be serologically positive\n             for human immunodeficiency virus (HIV).\n\n         24. Previous allogeneic bone marrow transplant or non-leukocyte depleted whole blood\n             transfusion within 120 days of genetic sample collection will exclude patients from\n             the pharmacogenetic portion of the study. If a patient declines to participate in the\n             optional exploratory pharmacogenetic research, there will be no penalty or loss of\n             benefit to the patient. The patient will not be excluded from other aspects of the\n             study.Xx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is limited to a single site, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXRecurrent disease that presents >100 days after, or minimal residual disease (MRD) that presents > 30 days after either:Xx_NEWLINE_xXPrior regimen must be within 6 months of registrationXx_NEWLINE_xXPrior chemotherapy, other investigational agents, or radiation must be discontinued for at least 28 days prior to the first administration of COTI-2. Hormone treatments must be discontinued for at least 28 days prior to the first administration of COTI-2.Xx_NEWLINE_xXPatients must be at least 28 days past their last course of lymphoma or CLL treatment, at least 84 days past their last course of rituximab treatment. Patients with pre-existing severe or life threatening side effects/conditions from prior therapy or due to other diseases may not be enrolledXx_NEWLINE_xXPart 2: Subjects who have received any amount of rituximab within 365 days of planned dose day 1 must have a serum rituximab level of <500 ng/mg documented by the study's reference laboratory prior to the initiation of dosing. Potential subjects who have received any other anti CD20 MAb therapy (obinutuzumab, ofatumumab, or ibritumomab tiuxetan) must be at least 8 half-lives past their last dose prior to initiation of study drug dosing. Washout periods for these drugs are as follows:Xx_NEWLINE_xXobinutuzumab (terminal half-life in NHL = 36.8 days); required washout = 184 days (26 weeks)Xx_NEWLINE_xXofatumumab (terminal half-life in CLL = 17.6 days); required washout = 88 days (13 weeks)Xx_NEWLINE_xXPatients must not have received any vaccines for 28 days prior to administration of their first dose of MT-3724 and should not receive any vaccine during the study or within 28 days after their last dose of MT-3724.Xx_NEWLINE_xXPrior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drugXx_NEWLINE_xXLast dose with any of the following agents including but not limited to: etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, or efalizumab <28 days prior to first dose of study drugXx_NEWLINE_xXPatient has received an investigational drug within 14 days of enrollmentXx_NEWLINE_xXSystemic corticosteroids are permissible in the following circumstances:\r\n* Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (=< 7 days) must have been discontinued at least 7 days prior to study treatment\r\n* Ongoing administration of a stable dose of corticosteroid therapy (previously received for >= 30 days) is permissible provided there is evidence of measurable disease and there will be no increase in steroid dose during the clinical trialXx_NEWLINE_xXConcurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc.) within 28 days of the first dose of study drugXx_NEWLINE_xXRecent infection requiring intravenous anti-infective treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXTreatment with any investigational product within 28 days prior to Screening.Xx_NEWLINE_xXFemale subjects who are breastfeeding, or intend to breastfeed during the duration of the study and for 30 days following the last dose of study drug.Xx_NEWLINE_xXPatients must be able to avoid direct contact with pregnant or nursing women, infants and immunocompromised individuals during the days of reolysin treatment and for two days afterXx_NEWLINE_xXNo systemic treatment in the previous 28 days.Xx_NEWLINE_xXInability to stop antiplatelet and Coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife systemXx_NEWLINE_xXWide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ?28 days or limited field radiation for palliation ?7 days prior to starting study drug or has not recovered from side effects of such therapy.Xx_NEWLINE_xXEvidence of hemoptysis within the last 7 days.Xx_NEWLINE_xXObtained =< 14 days prior to registration: Platelet count >= 75000/mm^3Xx_NEWLINE_xXCOHORT B ONLY: Obtained =< 14 days prior to registration: N-terminal pro b-type natriuretic peptide (NT-ProBNP) < 7500 ng/dLXx_NEWLINE_xXRadiotherapy =< 14 days prior to registration; NOTE: if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXBetween days 28 and 50 post transplantation at the time of initiation of the study drugXx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of baselineXx_NEWLINE_xXPatients must be off all disease modifying therapy for MDS for 28 days prior to initiation of study treatment; patients may receive hydrocortisone prophylactically to prevent transfusion reactionsXx_NEWLINE_xXBreastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drugXx_NEWLINE_xXCOHORT B, GROUP 7: GALLBLADDER CANCER OR CHOLANGIOCARCINOMA: If the patient has had decompression of the biliary tree within the last 14 days, stability of the bilirubin level needs to be confirmed with two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to registration); both the first and second measurement must be < 1.5 x institutional ULN (IULN); stability is defined as the second measurement being no more than one point higher than the firstXx_NEWLINE_xXPatients may not have fever (38.5*C) within 7 days of enrollmentXx_NEWLINE_xXHistory of bowel obstruction within 28 days from proposed start of treatmentXx_NEWLINE_xXPatients with human immunodeficiency virus (HIV)-1 may be eligible if they meet the following conditions:\r\n* CD4 cell count > 350 cells/mm3 obtained within 90 days prior to study start.\r\n* Plasma HIV-1 ribonucleic acid (RNA) below detected limit obtained by Food and Drug Administration (FDA)-approved assays for > 2 years on combination anti-retroviral therapy (cART). \r\n* Plasma HIV-1 RNA level of less than 40 copies/mL obtained by the Abbott m2000 assay or less than 20 copies/mL by Roche Taqman version (v)2.0 assay within 90 days prior to study start.\r\n* Plasma HIV-1 RNA greater than or equal to 0.4 copies/mL by single copy assay within 120 days prior to entry.\r\n* Receiving a stable cART regimen containing at least 3 agents (not including ritonavir if less than a 200 mg total daily dose) with no change in the components of antiretroviral therapy for at least 90 days prior to study entry.Xx_NEWLINE_xXTREATMENT WITH SJCAR19: Receiving systemic immunosuppressive therapy in the 14 days prior to CAR T-cell infusionXx_NEWLINE_xXInclusion Criteria:\n\n        Patients must meet all of the following criteria in order to be included in the study:\n\n          1. Male or female patients, 18 years of age or older at the time of consent.\n\n          2. Provide written informed consent prior to performing any study-related procedure.\n\n          3. Histologically or cytologically confirmed patients with advanced or metastatic solid\n             tumors for both Dose Escalation and Expansion cohort.\n\n          4. Patients for whom no available treatment options are known to confer clinical benefit.\n\n          5. Measurable disease (i.e., at least one measurable lesion per Response Evaluation\n             Criteria in Solid Tumors (RECIST), version 1.1.\n\n          6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\n          7. At least 21 days since the last chemotherapy, immunotherapy, biological or radiation,\n             or approved tyrosine kinase inhibitor (TKI) therapy.\n\n          8. Adequate organ function defined as:\n\n               -  Hepatic:\n\n                    -  Serum alanine aminotransferase (ALT) ?3 × upper limit of normal (ULN), ?5 ×\n                       ULN in the presence of liver metastases\n\n                    -  Serum aspartate aminotransferase (AST) ?3 × ULN, ?5 × ULN in presence of\n                       liver metastases\n\n                    -  Serum bilirubin ?1.5 × ULN\n\n               -  Renal:\n\n                  - Creatinine clearance >60 mL/minute using Cockcroft Gault equation\n\n               -  Hematologic:\n\n                    -  White Blood Count (WBC) ?3,500/µL\n\n                    -  Absolute neutrophil count ?1000/µL\n\n                    -  Absolute lymphocytes ? 0.5 ×10 9/l\n\n                    -  Platelets ?75,000/µL\n\n                    -  Hemoglobin ?9 g/dL\n\n          9. Normal coagulation profile except:\n\n               -  International Normalized Ratio (INR) within 1.5 × ULN\n\n               -  Activated partial thromboplastin time (aPTT) within 1.5 × ULN\n\n         10. Patient is willing and able to comply with all protocol required assessments, visits,\n             and procedures, including pretreatment tumor biopsy. Archival tumor biopsies are\n             acceptable at baseline.\n\n         11. Females of childbearing potential must have negative serum pregnancy test prior to\n             starting study therapy, and agree to use a reliable form of contraceptive during the\n             study treatment period and for at least 120 days following the last dose of study\n             drug.\n\n             Subject not of childbearing potential (i.e., permanently sterilized, postmenopausal)\n             can be included in study. Postmenopausal is defined as 12 months with no menses\n             without an alternative medical cause.\n\n             Male patients must agree to use an adequate method of contraception during the study\n             treatment period and for at least 120 days following the last dose of study drug.\n\n         12. Cannot be breast feeding.\n\n        Exclusion Criteria:\n\n        Patients meeting any of the following criteria are ineligible to participate in this study:\n\n          1. Patients currently participating in or has participated in a study of an\n             investigational anticancer therapy received within 28 days prior to the first dose of\n             OBI-888.\n\n          2. Has undergone a major surgical procedure (as defined by the investigator) or\n             significant traumatic injury within 28 days prior to the first dose of OBI-888.\n\n          3. Presence of an active autoimmune or inflammatory disease requiring systemic treatment\n             within the past 2 months or a documented history of clinically severe autoimmune\n             disease that requires systemic steroids or other immunosuppressive medications. Local\n             steroid injections, intermittent use of topical, inhaled, ophthalmologic,\n             intra-articular, topical, or intranasal corticosteroids, or systemic corticosteroids\n             at physiologic doses not to exceed 10 mg/day of prednisone or equivalent would not be\n             excluded from the study.\n\n          4. Presence of primary immunodeficiency or receiving systemic steroids of >10 mg/day of\n             prednisone or equivalent or other immunosuppressive agents within 7 days prior to the\n             first dose of OBI 888.\n\n          5. Has active bacterial, viral, fungal, or mycobacterial infection requiring systemic\n             therapy, including known infection with human immunodeficiency virus (HIV) or active\n             infection with hepatitis B virus or hepatitis C virus.\n\n          6. Patients with a history of solid organ transplant.\n\n          7. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to\n             Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse\n             Events [NCI CTCAE] version 4.03), except for alopecia and laboratory values listed in\n             the inclusion criteria.\n\n          8. Receipt of any prior therapy targeting Globo H.\n\n          9. Prior anti cancer mAb within 3 weeks or 5 half lives prior to the first dose of OBI\n             888.\n\n         10. Known hypersensitivity to OBI 888 or its excipients.\n\n         11. Has known central nervous system metastases and/or leptomeningeal metastases.\n\n         12. Any medical co morbidity or psychiatric illness that is life threatening or, in the\n             opinion of the Investigator, renders the patient unsuitable for participation in a\n             clinical trial due to possible noncompliance, would place the patient at an\n             unacceptable risk and/or potential to affect interpretation of results of the study.\n\n         13. Unable or unwilling to complete any study procedures or discontinue any prohibited or\n             restricted medications for the duration of the study.\n\n         14. Positive serum pregnancy test.\n\n         15. Is receiving any concurrent prohibited medicationXx_NEWLINE_xXPatients must be able to start treatment (androgen suppression [AS] or radiation) within 120 days of study registrationXx_NEWLINE_xXVaccination within 28 days of the first dose of study drugs and while on trial is prohibited, except for administration of inactivated vaccines (for example, inactivated influenza vaccine).Xx_NEWLINE_xXWithin 14 days of the first dose of study drug: Neutrophils >= 1500/uLXx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of baseline.Xx_NEWLINE_xXEXCLUSION - PARTICIPANT: Participant received prior chemotherapy or any other targeted therapies within the past 28, or palliative radiation within the past 14 days, prior to going on-study.Xx_NEWLINE_xXPatients must have discontinued enzalutamide at least 28 days prior to enrollment.Xx_NEWLINE_xXPatients on 5-alpha reductase inhibitors such as finasteride or dutasteride must stop medication at least 28 days prior to study entry.Xx_NEWLINE_xXThe effects of enzalutamide and CRLX101 on the developing human fetus are unknown. For this reason and because androgen receptor antagonists and topoisomerase I inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, all study subjects must agree to use a condom during the study treatment period and for 120 days following the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.Xx_NEWLINE_xXPatients who are receiving any other investigational agents. A minimum washout period of 28 days is required prior to the initiation of on study treatment.Xx_NEWLINE_xXSystemic therapy with immunosuppressive agents within 7 days before the start of treatment; or use of any investigational drug within 28 days before the start of trial treatment.Xx_NEWLINE_xXAt least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occurXx_NEWLINE_xXRadiotherapy ? 14 days prior to registration; NOTE: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of study drugsXx_NEWLINE_xXUse of any of the following:\r\n* Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis; physiologic replacement, topical, and inhaled steroids are permitted\r\n* Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) within 90 days of leukapheresis\r\n* Cytotoxic chemotherapeutic agents within 1 week of leukapheresis; oral chemotherapeutic agents are allowed if at least 3 half-lives have elapsed prior to leukapheresis\r\n* Low dose chemotherapy (e.g., bortezomib, lenalidomide, cyclophosphamide ? 300 mg/m^2) given after leukapheresis to maintain disease control must be stopped ? 7 days prior to initiation of lymphodepleting chemotherapy\r\n* Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis\r\n* Experimental agents within 4 weeks of leukapheresis unless progression is documented on therapy and at least 3 half-lives have elapsed prior to leukapheresis\r\n* Daratumumab or any other anti-CD38 monoclonal antibody therapy within 30 days of leukapheresisXx_NEWLINE_xXPatients with prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 28 days prior to enrollment, except if the investigator has assessed that all residual treatment-related toxicities have resolved or are minimal and feel the patient is otherwise suitable for enrollmentXx_NEWLINE_xXWilling to be smoke-free for 7 daysXx_NEWLINE_xXRadiotherapy within the last 21 days prior to C1D1 (limited field palliative radiation is allowed if ? 14 days prior to C1D1);Xx_NEWLINE_xXMale subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug administration until 90 days after the last dose of study drug.Xx_NEWLINE_xXSubject has received biologic agents (e.g. monoclonal antibodies) for anti-neoplastic intent within 30 days prior to first dose of study drugXx_NEWLINE_xXPatients on dialysis within 7 days of enrollment.Xx_NEWLINE_xXObtained =< 14 days prior to registration: Total cholesterol =< 1.5 x ULNXx_NEWLINE_xXObtained =< 14 days prior to registration: Triglycerides =< 1.5 x ULNXx_NEWLINE_xXUse of St. John’s wort =< 7 days prior to registrationXx_NEWLINE_xXCreatinine =< 2.5 (within 14 days of PET imaging)Xx_NEWLINE_xXRecovery from the toxic effects of prior therapy, with a minimum time of: \r\n* >= 28 days elapsed from the administration of any investigational agent\r\n* >= 28 days elapsed from the administration of any prior cytotoxic agents, except\r\n* >= 14 days from vincristine, >= 21 days from procarbazine, and >= 42 days from nitrosureas\r\n• >= 14 days elapsed from administration of any non-cytotoxic agent (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid) \r\nInvestigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% per year when used consistently and correctly.Xx_NEWLINE_xXAnticancer treatment within designated period before enrollment including\r\n* Minor surgical procedure (such as biliary stenting) within 14 days\r\n* Major surgical procedure or radiation treatment within 28 days\r\n* Chemotherapy or experimental drug treatment with published half-life known to be 72 hours within 14 days\r\n* Experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days\r\n* Radiotherapy for measurable lesions delivered in a normal organ-sparing technique within 21 days (except for palliative radiotherapy)Xx_NEWLINE_xXTreated with at least one line of chemotherapy in the palliative setting or with neoadjuvant or adjuvant chemotherapy within the prior six months; the allowable window between treatments is 21 days for chemotherapy or a tyrosine kinase inhibitor (TKI) or 5 half-lives for a TKI (whichever is shorter), 21 days and progression by CT for immunotherapy, 21 days for RT, 21 days for surgery, or 28 days for an investigational agentXx_NEWLINE_xXOther anti-neoplastic investigational agents currently or within 30 days prior to apheresis (i.e. start of protocol therapy)Xx_NEWLINE_xXCardiac function (12 lead- electrocardiogram [ECG] versus [vs] non-12 lead ECG), performed within 14 days prior to day 1 of protocol therapyXx_NEWLINE_xX3-14 days from prior TKI depending on half-life.Xx_NEWLINE_xXReceived treatment with anti-CTLA-4 antibody within 30 days prior to the start of CMP-001.Xx_NEWLINE_xXReceived systemic glucocorticoids within 28 days prior to the first dose of enzalutamide and/or CORT125281, or requirement for chronic or frequently used systemic glucocorticoids for medical conditions (e.g., rheumatoid arthritis, immunosuppression after organ transplantation)Xx_NEWLINE_xXSystemic therapy with immunosuppressive agents within 7 days before the start of treatment; or use of any investigational drug within 28 days before the start of trial treatment.Xx_NEWLINE_xXDaily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug.Xx_NEWLINE_xXPatients with prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 28 days prior to the first drug administration except if the investigator has assessed that all residual treatment-related toxicities have resolved or are minimal and feel the patient is otherwise suitable for enrollmentXx_NEWLINE_xXPatients receiving prednisone > 0.1 mg/kg/day or equivalent at time of enrollment, or who have received anti- thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.Xx_NEWLINE_xXInvestigational drug use within 28 days of C1D1Xx_NEWLINE_xXCLL therapy, with the exception of ibrutinib within the following timeframes:\r\n* Chemotherapy, external beam radiation therapy, anticancer antibodies within 30 days prior to the first dose of drug on this study\r\n* Corticosteroid use >= 20mg prednisone within 1 week prior to first dose on this study\r\n* Radio- or toxin-conjugated antibody therapy within 10 weeks prior to first dose on this study\r\n* Allogeneic stem cell transplant within 6 months prior to first dose on this studyXx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 28 days before the first study treatmentXx_NEWLINE_xXHas received wide field radiotherapy (including therapeutic radioisotopes such as radium 223) ? 28 days or limited field radiation for palliation ? 14 days prior to starting study drug or has not recovered from side effects of such therapy.Xx_NEWLINE_xXFor cohort 4 only (glioblastoma), patients must either not be receiving steroids, or be on a stable dose of steroids for at least five days prior to registrationXx_NEWLINE_xXObtained within 14 days prior to randomization/registration: neutrophils >= 1500/uLXx_NEWLINE_xXReceived hydroxyurea therapy within 28 days (4 weeks) before the first dose of any study drugXx_NEWLINE_xXSystemic antineoplastic therapy or radiotherapy for other malignant conditions within 14 days before the first dose of any study drugXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** Solid tumor patients: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** Lymphoma patients: a waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e. corticosteroid, vincristine, thioguanine[6MP], and/or methotrexate)\r\n** >=14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy; additionally, patients must have fully recovered from all acute toxic effects of prior therapy; Note: cytoreduction with hydroxyurea must be discontinued >= 24 hours prior to the start of protocol therapy\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days must have elapsed from the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Hematopoietic growth factors: >= 14 days must have elapsed from the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days must have elapsed from the last dose of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without traumatic brain injury [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days must have elapsed from infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days must have elapsed from infusion\r\n* Cellular therapy: >= 42 days must have elapsed from last dose of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* External beam radiation (XRT)/external beam irradiation including protons: >= 14 days must have elapsed after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days must have elapsed from the last dose of systemically administered radiopharmaceutical therapy\r\n* Histone deacetylase (HDAC) inhibitors: Patients must not have received prior therapy with entinostat; patients who have received therapy with other HDAC inhibitors are eligibleXx_NEWLINE_xXPatients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroidXx_NEWLINE_xXThe most recent dose of olaratumab must have been received within 180 days of randomization in this study.Xx_NEWLINE_xXSubjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.Xx_NEWLINE_xXUse of any investigational drug within 14 days prior to the first dose of study drugXx_NEWLINE_xXMust have undergone a nephrectomy and/or metastasectomy ?28 days prior to signing informed consent and ?12 weeks prior to randomization.Xx_NEWLINE_xXDonor lymphocyte infusion (DLI) within 28 days prior to enrollmentXx_NEWLINE_xXCorticosteroid therapy for 7 days prior to enrollmentXx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 7 days prior to study entryXx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days with some exceptionsXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone morrow (BM) radiation\r\n** Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to palbociclib, ribociclib, abemaciclib or any other CDK4/6 inhibitorsXx_NEWLINE_xXAt Screening with a serum sample obtained within 14 days prior to the first study drug administration, andXx_NEWLINE_xXEnzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days of randomization.Xx_NEWLINE_xXFor patients selecting vinorelbine or gemcitabine as the TPC agent, patients may not receive yellow fever vaccine in the 28 days prior to randomization.Xx_NEWLINE_xXHave received treatment within 21 days of the initial dose of olaratumab with an investigational product or non-approved use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.Xx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatmentXx_NEWLINE_xXPatients must discontinue previous EGFR-TKI at least 7 days prior to study enrollmentXx_NEWLINE_xXConcomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugsXx_NEWLINE_xXBiopsy-proven HSIL (anal intraepithelial neoplasia 2 [AIN2] with a positive p16 stain, AIN 2-3, or AIN3) of the anal canal at either the squamocolumnar junction or distal anus, documented within 60 days prior to enrollment, but not less than 7 days prior to randomizationXx_NEWLINE_xXCluster of differentiation (CD)4 count >= 200 within 120 days prior to enrollment or plasma HIV-1 RNA < 200 copies/mL within 120 days prior to randomizationXx_NEWLINE_xXPatients may have received prior therapy including vincristine, irinotecan, or temozolomide; patients may not have previously been treated with combination therapy of irinotecan and temozolomide\r\n* Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n** Patients must not have received myelosuppressive chemotherapy within 3 weeks of starting protocol therapy, or a minimum of six weeks must have elapsed since prior nitrosourea chemotherapy\r\n** At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim\r\n** At least 7 must have elapsed since the last administration of any biologic agent\r\n** At least 14 days since the last dose of local palliative radiation therapy; greater than 6 months must have elapsed since the last day of treatment if given total body irradiation, craniospinal irradiation\r\n** Complete resolution of graft versus host disease and no current need for immunosuppressive medication; greater than 3 months must have elapsed since engraftment and no longer requiring transfusion of platelets or injection of colony stimulating factorsXx_NEWLINE_xXPatients must start therapy within 7 calendar days of registrationXx_NEWLINE_xXObtained within 28 days prior to registration: bilirubin < 2 mg/dlXx_NEWLINE_xXPART A DOSE ESCALATION\n\n        Inclusion Criteria: PART A Dose Escalation\n\n          1. 18-70 years of age\n\n          2. Histologically confirmed WHO grade IV glioblastoma\n\n          3. Unequivocal evidence of a tumor recurrence (any number of recurrences) or progression\n             after an initial treatment regimen (prior to enrollment on this study) consisting of\n             surgical intervention (tumor resection), radiation, and temozolomide chemotherapy (per\n             Stupp protocol), as assessed by MRI of the brain with and without contrast within 30\n             days prior to the initiation of injections of VBI-1901.\n\n          4. Recovery from the effects of surgery.\n\n          5. Corticosteroid (dexamethasone or equivalent) dosage ? 4mg daily that has been stable\n             or decreasing for at least 5 days.\n\n          6. Recovery from prior therapy toxicity defined as resolution of all treatment-related\n             adverse events (AEs) to Grade ? 1 or pre-treatment baseline (except alopecia).\n\n          7. Karnofsky performance status (KPS) score ? 70%.\n\n          8. Adequate organ function, including the following:\n\n               1. Absolute neutrophil count (ANC) ? 1,000/?L, platelets ? 100,000/?L\n\n               2. Serum creatinine < 1.5 × the upper limit of normal (ULN)\n\n               3. Bilirubin < 1.5 × ULN\n\n               4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN\n\n          9. Women of childbearing potential: negative urine pregnancy test within 14 days prior to\n             the start of VBI-1901 treatment.\n\n         10. Female subjects of childbearing potential and sexually active male subjects must agree\n             to use an acceptable form of contraception for heterosexual activity (i.e., oral\n             contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted\n             contraceptives, tubal ligation, or vasectomy of their sexual partner(s) for > 30 days\n             before Screening, during the study, and for 60 days after the last dose of study\n             drug).\n\n         11. Female subjects without childbearing potential (spontaneous amenorrhea for > 12 months\n             or surgically sterilized by tubal ligation, hysterectomy, or bilateral oophorectomy >\n             6 months before Screening) are eligible for inclusion without contraceptive use\n             restriction.\n\n         12. Able and willing to comply with protocol requirements, including being able to have an\n             MRI in the opinion of the Investigator.\n\n         13. Written consent has been obtained.\n\n         14. Tumor specimen available for central pathological review.\n\n        Exclusion Criteria: PART A Dose Escalation\n\n          1. Contrast-enhancing residual tumor that is associated with either diffuse sub-\n             ependymal or leptomeningeal dissemination.\n\n          2. Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or\n             equivalent or requirement of increasing dose of systemic corticosteroids during the 7\n             days prior to the start of VBI-1901 treatment.\n\n          3. Evidence of HCMV viremia in serum of > 18,200 (4.3Log10) IU/mL using FDA approved\n             COBAS® AmpliPrep/COBAS® TaqMan® HCMV test (Roche).\n\n          4. Surgical resection or major surgical procedure within 4 days prior to the start of\n             VBI- 1901, or stereotactic biopsy within 7 days prior to the start of VBI-1901.\n\n          5. Active infection requiring intravenous antibiotics or antiviral.\n\n          6. History of cancer (other than GBM or prostate) within the past 2 years that could\n             negatively impact survival and/or potentially confound tumor response assessments\n             within this study.\n\n          7. Known immunosuppressive disease or active systemic autoimmune disease such as systemic\n             lupus erythematosus, human immunodeficiency virus infection, Hepatitis B virus or\n             Hepatitis C virus infections. Subjects with vitiligo, type 1 diabetes mellitus,\n             hypothyroidism due to autoimmune condition only requiring hormone replacement therapy,\n             psoriasis not requiring systemic therapy, or conditions not expected to recur in the\n             absence of an external trigger are permitted to enroll.\n\n          8. Immunosuppressive agent within 4 weeks prior to the start of VBI-1901 treatment.\n\n          9. Evidence of intra-tumoral or peri-tumoral hemorrhage on baseline, other than those\n             that are ?Grade 1 and either post-operative or stable on at least 2 consecutive MRI\n             scans.\n\n         10. Any condition which in the investigator's opinion makes the subject unsuitable for\n             study participation.\n\n         11. Lack of family or social support structure that would preclude continued participation\n             in the study.\n\n        PART B\n\n        Inclusion Criteria: Part B\n\n          1. 18-70 years of age.\n\n          2. Histologically confirmed WHO grade IV glioblastoma.\n\n          3. Unequivocal evidence of a first tumor recurrence with measurable disease, defined as 1\n             cm but no greater than 3 cm of enhancing tissue measured in 2 planes (axial, coronal,\n             or sagittal) after an initial treatment regimen (prior to enrollment on this study)\n             consisting of surgical intervention (tumor resection), radiation, and temozolomide\n             chemotherapy (per Stupp protocol), as assessed by MRI of the brain with and without\n             contrast within 30 days prior to the initiation of injections of VBI-\n\n        1901.\n\n        4. At least 12 weeks since treatment per Stupp protocol prior to first dose of VBI-1901.\n\n        5. Recovery from the effects of surgery.\n\n        6. Corticosteroid (dexamethasone or equivalent) dosage ? 4mg daily that has been stable or\n        decreasing for at least 5 days.\n\n        7. Recovery from prior therapy toxicity, defined as resolution of all treatment-related\n        adverse events (AEs) to Grade ? 1 or pre-treatment baseline (except alopecia).\n\n        8. Karnofsky performance status (KPS) score ? 70%.\n\n        9. Adequate organ function, including the following:\n\n          1. Absolute neutrophil count (ANC) ? 1,000/?L, platelets ? 100,000/?L;\n\n          2. Serum creatinine < 1.5 × the upper limit of normal (ULN);\n\n          3. Bilirubin < 1.5 × ULN;\n\n          4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.\n\n             10. Women of childbearing potential must have a negative urine pregnancy test within\n             14 days prior to the start of VBI-1901 treatment.\n\n             11. Female subjects of childbearing potential and sexually active male subjects must\n             agree to use an acceptable form of contraception for heterosexual activity (i.e., oral\n             contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted\n             contraceptives, tubal ligation, or vasectomy of their sexual partner(s) for > 30 days\n             before Screening, during the study, and for 60 days after the last dose of study\n             drug).\n\n             12. Female subjects without childbearing potential (spontaneous amenorrhea for > 12\n             months or surgically sterilized by tubal ligation, hysterectomy, or bilateral\n             oophorectomy > 6 months before Screening) are eligible for inclusion without\n             contraceptive use restriction.\n\n             13. Able and willing to comply with protocol requirements, in the opinion of the\n             Investigator.\n\n             14. Written consent has been obtained.\n\n             15. Tumor specimen available for central pathological review.\n\n        Exclusion Criteria: Part B\n\n          1. Contrast-enhancing residual tumor that is any of the following:\n\n               1. Greater than 3 cm in 2 planes (axial, coronal, or sagittal);\n\n               2. Multi-focal (defined as two separate areas of contrast enhancement measuring at\n                  least 1 cm in 2 planes that are not contiguous on either fluid-attenuated\n                  inversion recovery (FLAIR) or T2 sequences);\n\n               3. Associated with either diffuse sub-ependymal or leptomeningeal dissemination.\n\n          2. Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or\n             equivalent or requirement of increasing dose of systemic corticosteroids during the 7\n             days prior to the start of VBI-1901 treatment.\n\n          3. Evidence of HCMV viremia in plasma of >18,200 (4.3log10) IU/mL using FDA approved\n             COBAS® AmpliPrep/COBAS® TaqMan® HCMV test (Roche).\n\n          4. Prior treatment involving immunotherapy, including oncolytic viruses, therapeutic\n             vaccination, or biologics (e.g. monoclonal antibodies) presumed to have\n             immunomodulatory effects.\n\n          5. Surgical resection or major surgical procedure within 14 days prior to the start of\n             VBI- 1901, or stereotactic biopsy within 14 days prior to the start of VBI-1901.\n\n          6. Radiation therapy, local therapy (except for surgical re-resection), or systemic\n             therapy following first recurrence/progressive disease. Excluded local therapies\n             include stereotactic radiation boost, implantation of carmustine biodegradable wafers\n             (Gliadel), intratumoral or convection- enhanced delivery administered agents, etc.\n\n          7. Active infection requiring intravenous antibiotics or antivirals.\n\n          8. History of cancer (other than GBM or prostate) within the past 2 years that has\n             metastatic or local recurrence potential and could negatively impact survival and/or\n             potentially confound tumor response assessments within this study.\n\n          9. Known immunosuppressive disease or active systemic autoimmune disease such as systemic\n             lupus erythematosus, human immunodeficiency virus infection, Hepatitis B virus or\n             Hepatitis C virus infections. Subjects with vitiligo, type 1 diabetes mellitus,\n             hypothyroidism due to autoimmune condition only requiring hormone replacement therapy,\n             psoriasis not requiring systemic therapy, or conditions not expected to recur in the\n             absence of an external trigger are permitted to enroll.\n\n         10. Immunosuppressive agent within 4 weeks prior to the start of VBI-1901 treatment.\n\n         11. Evidence of intra- or peri-tumoral hemorrhage on baseline MRI scan, other than those\n             that are ?Grade 1 and either post-operative or stable on at least 2 consecutive MRI\n             scans.\n\n         12. Any condition which in the investigator's opinion makes the subject unsuitable for\n             study participation.\n\n         13. Lack of family or social support structure that would preclude continued participation\n             in the study.Xx_NEWLINE_xXPrior Treatment\r\n* Patient must have failed at least one prior systemic therapy that included everolimus; disease progression or treatment intolerance leading to discontinuation is considered treatment failure\r\n* Prior treatment (except somatostatin analogs) with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, and/or radiation must be completed at least 28 days prior to registration\r\n* Prior treatment with somatostatin analogs is allowed, and continuation of treatment with somatostatin analogs while on cabozantinib/placebo is allowed provided that the patient has been on a stable dose for at least two months\r\n* Prior systemic treatment with radionuclide therapy must be completed at least 6 weeks prior to registration\r\n* Prior treatment with hepatic artery embolization (including bland embolization, chemoembolization, and selective internal radiation therapy) or ablative therapies is allowed if measurable disease remains outside of the treated area or if there is documented disease progression in a treated site; prior liver-directed or other ablative treatment must be completed at least 28 days prior to registration\r\n* Prior treatment with cabozantinib is not allowed\r\n* Patients should have resolution of any toxic effects of prior therapy (except alopecia and fatigue) to National Cancer Institute (NCI) CTCAE, version 5.0, grade 1 or less\r\n* Patients must have completed any major surgery at least 12 weeks prior to registration and any minor surgery (including uncomplicated tooth extractions) at least 28 days prior to registration; complete wound healing from major surgery must have occurred at least 28 days prior to registration, and complete wound healing from minor surgery must have occurred at least 10 days prior to registrationXx_NEWLINE_xXPatient History\r\n* No class III or IV congestive heart failure (CHF) within 6 months of registration\r\n* No clinically significant cardiac arrhythmia within 6 months of registration\r\n* No unstable angina or MI within 6 months of registration\r\n* No thromboembolic events within 6 months of registration (including [incl.] stroke, transient ischemic attack [TIA], deep vein thrombosis [DVT], & pulmonary embolism [PE])\r\n* No known history of congenital long QT syndrome\r\n* No uncontrolled hypertension within 14 days of registration (defined as systolic blood pressure [SBP] >= 150 mmHg and/or diastolic blood pressure [DBP] >= 90 mmHg despite optimal medical management)\r\n* No clinically significant GI bleeding within 6 months of registration\r\n* No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 6 months of registration including, but not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with history of bleeding, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation\r\n* No GI perforation within 6 months of registration\r\n* No known tumor invading the GI tract within 28 days of registration\r\n* No radiologic or clinical evidence of pancreatitis\r\n* No known cavitary lung lesions\r\n* No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage; (CT with contrast is recommended to evaluate such lesions)\r\n* No hemoptysis greater than 1/2 teaspoon (2.5 mL) or any other signs of pulmonary hemorrhage within the 3 months prior to registration\r\n* No known tumor invading or encasing any major blood vessels\r\n* No history of non-healing wounds or ulcers within 28 days of registration\r\n* No history of fracture within 28 days of registration\r\n* No brain metastases or cranial epidural disease unless adequately treated, stable, and off steroid support for at least 4 weeks prior to registration\r\n* No known medical condition causing an inability to swallow oral formulations of agents\r\n* No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib/placebo\r\n* No “currently active” second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ; patients are not considered to have a “currently active” malignancy if they have completed therapy and are free of disease for >= 3 yearsXx_NEWLINE_xXNon-oncology vaccines within 28 days prior to or after any dose of ipilimumabXx_NEWLINE_xXTreatment with investigational therapy within 28 days prior to randomisationXx_NEWLINE_xXObtained within 28 days prior to the first dose of cabozantinib: serum phosphorus >= 2.5 mg/dl.Xx_NEWLINE_xXObtained within 28 days prior to the first dose of cabozantinib: calcium >= 8 mg/dL.Xx_NEWLINE_xXObtained within 28 days prior to the first dose of cabozantinib: magnesium >= 1.2 mg/dL.Xx_NEWLINE_xXObtained within 28 days prior to the first dose of cabozantinib: potassium >= 3.0 meq/L.Xx_NEWLINE_xXNo increase in steroid dose within the past 7 daysXx_NEWLINE_xXAt least 30 days from any major surgeries including brain biopsy and have complete resolution of its effectsXx_NEWLINE_xXHas a diagnosis of immunodeficiency including human immunodeficiency virus (HIV) (HIV 1/2 antibodies) and is not on continuous daily immunosuppressive therapy within 7 days prior to the first dose of trial treatment; (an exception to this is the use of steroids for brain edema and resulting symptom); subjects may receive a stable or reducing dose of steroids (up to 8 mg dexamethasone or equivalent for at least 5 days prior to signing consent) to prevent or manage cerebral edema; subjects requiring over 8mg of dexamethasone per day on or five days prior to signing consent are excluded)Xx_NEWLINE_xXChemotherapy or radiotherapy within 14 days prior to starting study treatment; in case of monoclonal antibodies/biologics, within 28 days prior to starting study treatmentXx_NEWLINE_xXAdministration of investigational agents within 28 days prior to treatment initiationXx_NEWLINE_xXCreatine phosphokinase (CPK) ? ULN obtained ? 14 days prior to randomizationXx_NEWLINE_xXProthrombin time (PT) within normal limits (WNL)+/- 15 % unless on active anticoagulation obtained ? 14 days prior to randomizationXx_NEWLINE_xXUncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollmentXx_NEWLINE_xXUse of vasopressors within 7 days prior to Day 1Xx_NEWLINE_xXUse of any of the following:\r\n* Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis; physiologic replacement, topical, and inhaled steroids are permitted\r\n* Allogeneic hematopoietic stem cell transplant (allo-HSCT) within 90 days of leukapheresis\r\n* Cytotoxic chemotherapeutic agents within 1 week of leukapheresis; oral chemotherapeutic agents are allowed if at least 3 half-lives have elapsed prior to leukapheresis\r\n* Low dose chemotherapy (e.g., bortezomib, lenalidomide, cyclophosphamide =< 300 mg/m^2) given after leukapheresis to maintain disease control must be stopped >= 7 days prior to initiation of lymphodepleting chemotherapy\r\n* Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis\r\n* Experimental agents within 4 weeks of leukapheresis unless progression is documented on therapy and at least 3 half-lives have elapsed prior to leukapheresisXx_NEWLINE_xXSubjects (men and women) must agree to not donate sperm (males) or eggs (females) during and up to 120 days after the last dose of study treatmentXx_NEWLINE_xXInclusion Criteria: All subjects\n\n          1. Histologically confirmed diagnosis of B-cell follicular lymphoma based on the WHO 2008\n             classification of tumors of hematopoietic and lymphoid tissue.\n\n          2. ?2 prior systemic treatments for follicular lymphoma.\n\n          3. Previously received an anti-CD20 antibody and an appropriate alkylator-based\n             combination therapy.\n\n          4. Disease progression within 12 months after completion of most recent therapy or\n             refractory disease.\n\n          5. Presence of measurable disease.\n\n          6. Availability of archival tissue confirming diagnosis.\n\n          7. ECOG performance status of 0,1 or 2.\n\n          8. Life expectancy ?6 months.\n\n          9. Adequate bone marrow function.\n\n         10. Adequate renal and hepatic function.\n\n         11. Females of childbearing potential and non-sterile males must agree to use highly\n             effective methods of birth control throughout the course of study and at least up to\n             90 days after last dosing, or 18 months after the last dose of obinutuzumab, whichever\n             is longer.\n\n         12. Male subjects are eligible if vasectomized or if they agree to the use of barrier\n             contraception in combination with other methods during the study treatment period and\n             for ? 90 days after the last dose of BGB-3111.\n\n         13. Ability to provide the written informed consent and can understand and comply with the\n             requirements of the study.\n\n        Exclusion Criteria: All subjects\n\n          1. Prior exposure to a BTK inhibitor.\n\n          2. Known central nervous system involvement by leukemia or lymphoma.\n\n          3. No evidence of transformation from follicular lymphoma to other aggressive histology.\n\n          4. No allogeneic hematopoietic stem cell transplantation within 12 months of enrollment\n\n          5. Prior malignancy within the past 5 years, except for basal or squamous cell skin\n             cancer, superficial bladder cancer, carcinoma in situ of the cervix of breast, or\n             localized Gleason score 6 prostate\n\n          6. Clinically significant cardiovascular disease.\n\n          7. Major surgery or significant injury ? 4 weeks prior to start of study treatment.\n\n          8. Active fungal, bacterial or viral infection requiring systemic treatment.\n\n          9. History of severe bleeding disorder.\n\n         10. History of stroke or intracranial hemorrhage within 6 months before first study drug.\n\n         11. Severe or debilitating pulmonary disease.\n\n         12. Known human immunodeficiency virus (HIV) or active hepatitis B or C.\n\n         13. Unable to swallow capsules or significant gastrointestinal disease that would\n             interfere with drug absorption.\n\n         14. Requires ongoing treatment with a strong CYP3A inhibitor or inducer\n\n         15. Pregnant or nursing females.\n\n         16. Vaccination with live vaccine within 35 days prior to first dose.\n\n         17. Ongoing drug or alcohol addiction.\n\n         18. Hypersensitivity to BGB-3111, known ingredients of BGB-3111 or obinutuzumab.\n\n         19. Participation in another therapeutic trial.Xx_NEWLINE_xXInclusion criteria\n\n        1.Provision of informed consent prior to any study specific procedures 2.Patients must be\n        male or female ?18 years of age. 3.Progressive cancer at the time of study entry with a\n        life expectancy of ?16 weeks 4.Histologically or cytologically confirmed TNBC with evidence\n        of metastatic disease as per ASCO-CAP HER2 guideline recommendations 2013 5.Patients must\n        have received at least 1 and no more than 2 prior lines of treatment for metastatic disease\n        with an anthracycline (eg, doxorubicin, epirubicin) and/or a taxane (eg, paclitaxel,\n        docetaxel) unless contraindicated, in either the neo-adjuvant, adjuvant or metastatic\n        setting.\n\n        6.Confirmed presence of qualifying HRR mutation or absence of any HRR mutation in tumour\n        tissue by the Lynparza HRR assay.\n\n        7.At least one measurable lesion that can be accurately assessed at baseline by computed\n        tomography (CT) (magnetic resonance imaging [MRI] where CT is contraindicated) and is\n        suitable for repeated assessment as per RECIST 1.1.\n\n        8.Patients must have normal organ and bone marrow function measured within 28 days prior to\n        randomisation as defined by protocol 9.ECOG PS 0-1 within 28 days of randomisation.\n        10.Patients must be willing to comply with the protocol requirements Exclusion criteria\n\n          1. Cytotoxic chemotherapy, hormonal or non hormonal targeted therapy within 21 days of\n             Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 21 or\n             more days before Cycle 1 Day 1. The patient can receive a stable dose of\n             bisphosphonates or denosumab for bone metastases, before and during the study as long\n             as these were started at least 5 days prior to study treatment.\n\n          2. More than 2 prior lines of cytotoxic chemotherapy for metastatic disease.\n\n          3. Previous randomisation in the present study.\n\n          4. Previous treatment with a PARP inhibitor (including olaparib) or other DDR inhibitor\n             (unless treatment was for less than 3 weeks duration and at least 12 months have\n             elapsed between the last dose and randomisation. Patients that did not tolerate prior\n             treatment are excluded).\n\n          5. Exposure to a small molecule IP within 30 days or 5 half-lives (whichever is longer)\n             prior to randomisation.The minimum washout period for immunotherapy shall be 42 days.\n\n          6. Patients with MDS/AML or with features suggestive of MDS/AML.\n\n          7. Patients with second primary cancer, EXCEPTIONS: adequately treated non melanoma skin\n             cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ\n             (DCIS), stage 1 grade 1 endometrial carcinoma, or other solid tumours curatively\n             treated with no evidence of disease for ? 5 years prior to study entry.\n\n          8. Mean resting corrected QTc interval using the Fridericia formula (QTcF) >470\n             msec/female patients and >450 msec for male patients or congenital long QT syndrome.\n\n          9. Any of the protocol specified cardiac diseases currently or within the last 6 months\n             defined by New York Heart Association (NYHA) ? Class 2:\n\n         10. Concomitant use of known strong cytochrome P (CYP) 3A inhibitors or use of known\n             strong or moderate CYP3A inducers.\n\n         11. Persistent toxicities (? CTCAE grade 2) caused by previous cancer therapy, excluding\n             alopecia and CTCAE grade 2 peripheral neuropathy.\n\n         12. Major surgery within 2 weeks of starting study treatment: patients must have recovered\n             from any effects of any major surgery.\n\n         13. Immunocompromised patients, eg,human immunodeficiency virus (HIV) patients.\n\n         14. Patients with known active hepatitis (B or C).\n\n         15. Patients considered a poor medical risk due to a serious, uncontrolled medical\n             disorder, non malignant systemic disease or active, uncontrolled infection.\n\n         16. Patients with symptomatic uncontrolled brain metastases.\n\n         17. Patients unable to swallow orally administered medication and patients with\n             gastrointestinal disorders likely to interfere with absorption of the study\n             medication.\n\n         18. Patients with a known hypersensitivity to olaparib, AZD1775, AZD6738, or any of the\n             excipients of the products.\n\n         19. Pregnant or breast feeding women.Xx_NEWLINE_xXSystemic antineoplastic therapy or radiotherapy within 14 days before the first dose of any study drug, except for hydroxyureaXx_NEWLINE_xXAt least 30 days from any major surgeries including brain biopsy and have complete resolution of its effectsXx_NEWLINE_xX> 14 days since any prior therapy for AML excluding hydroxyureaXx_NEWLINE_xXPatients must have discontinued all biologic therapy at least 14 days prior to registrationXx_NEWLINE_xXReceipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) before the first planned dose of study drugsXx_NEWLINE_xXAnticoagulant drugs (e.g., warfarin) that could not be withdrawn during the 10 days prior to the VTP procedure or antiplatelet drugs (e.g. aspirin) that could not be withdrawn during the 10 days prior to the VTP procedure and 3 days after VTP;Xx_NEWLINE_xXSignificant clinical change in health in the past 30 daysXx_NEWLINE_xXUse of finasteride within 30 days prior to therapy PSA should not be obtained prior to 30 days after stopping finasterideXx_NEWLINE_xXUse of dutasteride within 90 days prior to therapy; PSA should not be obtained prior to 90 days after stopping dutasterideXx_NEWLINE_xXChemotherapy or immunotherapy =< 28 days prior to registrationXx_NEWLINE_xXHas had relapse prior to primary neutrophil engraftment or =< 21 days post HCTXx_NEWLINE_xXHas been on immunosuppressant therapy within 7 days prior to the first dose of pembrolizumabXx_NEWLINE_xXRadiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXHistory/physical examination within 7 days prior to registrationXx_NEWLINE_xXPatients treated metastatic lesions to the brain may be enrolled after completing stereotactic radiosurgery (may enroll 14 days after treatment) or whole brain radiation (may enroll 14 days after treatment) and being weaned off corticosteroids (may enroll 14 days after weaning)Xx_NEWLINE_xXPatients with untreated spinal cord compression; patients with spinal cord compression may be enrolled if stable after completing surgery (may enroll 14 days after surgery) or radiation (may enroll 14 days after treatment) and must be off corticosteroids for at least 14 days prior to the start of study treatmentXx_NEWLINE_xXWithin 7-10 days of study drug administration: Urinalysis no greater than 1+ hematuria or proteinuriaXx_NEWLINE_xXExpected survival of > 90 daysXx_NEWLINE_xXNeutrophils >= 1500/uL within 14 days of registrationXx_NEWLINE_xXAcute VOC ending 7 days prior to first dosingXx_NEWLINE_xXReceived blood products within 30 days to first dosingXx_NEWLINE_xXHistory of any of the following within the last 3 months before administration of the first dose of study drug:Xx_NEWLINE_xXStable disease (SD) for >=30 days, without steroid use (or stable steroid dose established for >=14 days before the first dose of TAK-931).Xx_NEWLINE_xXNeutrophils >= 1500/microL within 14 days of study registration.Xx_NEWLINE_xXPlatelets >= 100 x 10^3/microL within 14 days of study registration.Xx_NEWLINE_xXSubject has no significant worsening in clinical status for a minimum of 7 days prior to first dose of study drug.Xx_NEWLINE_xXMedically supervised (ie, performed in a clinic) pregnancy testing, including those who commit to true abstinence. Two pregnancy tests must be conducted prior to starting pomalidomide. The first pregnancy test must be performed 10 to 14 days prior to the start of pomalidomide and the second pregnancy test must be performed within 24 hours prior to starting pomalidomide. Females of childbearing potential with regular or no menstrual cycles must also agree to have pregnancy tests weekly for the first 28 days study participation, every 28 days while on study, at study treatment discontinuation, and at Day 28 following pomalidomide discontinuation. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days of study participation and then every 14 days while on study, at study treatment discontinuation visit, and at Days 14 and 28 following pomalidomide discontinuation.Xx_NEWLINE_xXMyelosuppressive chemotherapy, immunotherapy, or any investigational agent: ? 21 days (? 42 days if a nitrosourea) prior to screening.Xx_NEWLINE_xXImmunomodulatory therapy: ? 28 days prior to screening.Xx_NEWLINE_xXObtained within 21 days prior to randomization/registration: Neutrophils >= 1500/uL.Xx_NEWLINE_xXHave adequate coagulation functioning within 15 days prior to start of study treatment, defined by either of the following criteria:Xx_NEWLINE_xXAdequate thyroid function within 14 days prior to registration defined as serum thyroid-stimulating hormone (TSH) within the normal rangeXx_NEWLINE_xXMust not have received myelosuppressive chemotherapy within 21 days prior to study drug administration (42 days if prior nitrosourea).Xx_NEWLINE_xXMust not have received an antineoplastic targeted therapy within 14 days.Xx_NEWLINE_xXMust not have received radiotherapy (XRT) within 14 days prior to study drug administration (small field) or 42 days for craniospinal XRT, or if ?50% radiation of pelvis.Xx_NEWLINE_xXAt least 84 days must have elapsed after stem cell infusion prior to study drug administrationXx_NEWLINE_xXParticipants receiving corticosteroids who have not been on a stable dose for at least 7 days prior to study drug administration.Xx_NEWLINE_xXLaparoscopic procedure or open biopsy within 7 days prior to study drug administrationXx_NEWLINE_xXFine needle aspirate within 3 days prior to study drug administration.Xx_NEWLINE_xXFemale subject who is of childbearing potential must not donate ova starting at screening and throughout the study and for 28 days after the final study drug administration.Xx_NEWLINE_xXSubject is unlikely to survive 30 days.Xx_NEWLINE_xXHerbal preparations are not allowed throughout the study, and should be discontinued 14 days prior to initiation of study treatmentXx_NEWLINE_xXAny major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to study enrollment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to study enrollmentXx_NEWLINE_xXSerum direct bilirubin =< 2 mg/dL (34 umol/L) within 21 days prior to initiation of therapyXx_NEWLINE_xXPatient has used any investigational drugs, biologics (vaccines, antibodies), or devices within 30 days prior to study treatment or has plans to use any of these during the course of the studyXx_NEWLINE_xXCHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Urinalysis within 14 days demonstrating that no urinary tract infection is presentXx_NEWLINE_xXAble to be off prednisone or other immunosuppressive medications for at least 3 days prior to FATE-NK100 cell infusion (excluding preparative regimen premedications)Xx_NEWLINE_xXWashout period of at least 14 days after any approved or experimental tumor directed therapy prior to start of cyclophosphamide and fludarabineXx_NEWLINE_xXPatients who have been treated with any investigational drug within 28 days prior to the first dose of study medication, or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapyXx_NEWLINE_xXParticipants with measurable disease that has progressed are eligible if prior surgery or locoregional therapy occurred > 28 days prior to enrollmentXx_NEWLINE_xXTherapy with biologic agents (non-myelosuppressive) must have been completed >= 7 days prior to study entry; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occurXx_NEWLINE_xXRadiotherapy =< 14 days prior to registration; NOTE: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXHas had monoamine oxidase inhibitors within 21 days before screeningXx_NEWLINE_xXPrior experimental therapy within 30 days of enrollmentXx_NEWLINE_xXInclusion Criteria:\n\n        Disease Related\n\n          1. Subject has confirmed histologic or cytologic evidence of metastatic pancreatic cancer\n             and has no prior treatment for metastatic pancreatic cancer.\n\n          2. Subject has measurable disease using Response Evaluation Criteria in Solid Tumors\n             (RECIST) v 1.1.\n\n          3. Subject has a life expectancy of at least 3 months.\n\n          4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n\n             Demographic\n\n          5. Males or females ? 18 years of age\n\n          6. Subject must be able to swallow capsules\n\n          7. Subject must have adequate venous access for intravenous (IV) infusion\n\n             Laboratory\n\n          8. Subject has hemoglobin ? 9.0 g/dL at Screening\n\n          9. Subject has absolute neutrophil count (ANC) ? 1.5 x 109/L at Screening\n\n         10. Subject has platelet count ? 100 x 109/L at Screening\n\n         11. Subject has serum creatinine ? 1.5 times the upper limit of normal (ULN) at Screening.\n             Subjects with serum creatinine levels > 1.5 times the ULN must have a 24-hour urine\n             creatinine clearance ? 60 mL/min\n\n         12. Subject has serum bilirubin ? 1.5 times the ULN (except in subjects with Gilbert's\n             Syndrome who must have serum bilirubin < 3.0 x ULN)\n\n         13. Subject has aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT;\n             SGPT) ? 2.5 times the ULN (OR, AST and ALT ? 5 times the ULN in the presence of known\n             liver metastases)\n\n         14. Subject has alkaline phosphatase ? 2.5 times the ULN (OR ? 5 times the ULN in the\n             presence of known liver or bone metastases)\n\n         15. Subject has normal coagulation parameters (prothrombin time [PT] and/or international\n             normalized ratio [INR], and partial thromboplastin time [PTT] within normal limits\n             [<1.2 x ULN])\n\n         16. Subject has potassium concentration within normal range, or correctable with\n             supplements.\n\n         17. Oxygen saturation by pulse oximetry ? 92% at rest.\n\n         18. For women of childbearing potential: Negative serum pregnancy test during screening\n             and negative serum or urine pregnancy test at start of study therapy (Cycle1 Day 1).\n\n             Reproductive\n\n         19. For female subjects of childbearing potential, willingness to abstain from\n             heterosexual intercourse or use a protocol-recommended method of contraception from\n             the screening visit throughout the study treatment period and for 30 days following\n             the last dose of study drug.\n\n         20. Female subjects of non-childbearing potential defined as having amenorrhea for at\n             least 24 consecutive months, a documented hysterectomy, or a documented bilateral\n             oophorectomy)\n\n         21. For fertile male subjects having intercourse with females of childbearing potential,\n             willingness to abstain from heterosexual intercourse or use a protocol-recommended\n             method of contraception from the start of study therapy throughout the study treatment\n             period and for 30 days following the last dose of study drug and to refrain from sperm\n             donation from the start of study treatment throughout the study treatment period and\n             for 30 days following the last dose of study drug.\n\n             Ethical\n\n         22. In the judgment of the investigator, participation in the protocol offers an\n             acceptable benefit-to-risk ratio when considering current disease status, medical\n             condition, and the potential benefits and risks of alternative treatments for the\n             subject's cancer.\n\n         23. Before any study-specific procedure, the appropriate written informed consent must be\n             obtained\n\n        Exclusion Criteria:\n\n        Disease Related\n\n          1. Subject has primary brain tumors or clinical evidence of active brain metastasis\n\n          2. Subject has undergone major surgery within 4 weeks of the start of study treatment.\n             Laparoscopy and central venous catheter placement are not considered major surgery\n\n             Medications\n\n          3. Subject has a history of systemic corticosteroid use within 7 days before Day 1 of\n             Cycle 1\n\n             General\n\n          4. Subject has an active infection requiring parenteral or oral antibiotics within 2\n             weeks before planned start of study therapy\n\n          5. Subject has uncontrolled diabetes as assessed by the investigator\n\n          6. Subject has a second malignancy other than curatively resected basal cell carcinoma of\n             the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or\n             other cancers treated with curative intent and no known active disease within 3 years\n             before planned start of study therapy\n\n          7. Subject has an active infection of hepatitis B, hepatitis C or human immunodeficiency\n             virus\n\n          8. Female subjects who are pregnant, planning a pregnancy or breast feeding during the\n             study\n\n          9. Subject has a high cardiovascular risk, including, but not limited to, subjects with\n             congestive heart failure (New York Heart Association [NYHA] Class III or IV), cardiac\n             arrhythmia, unstable angina, coronary stenting or acute coronary syndromes within 6\n             months before planned start of study therapy or r myocardial infarction within one\n             year before planned start of study therapy\n\n         10. Subject has a history of peripheral artery disease (e.g., claudication, Leo Buerger's\n             disease).\n\n         11. Subject has a history of prior allogeneic bone marrow progenitor cell or solid organ\n             transplantation.\n\n         12. Subject has known acute or chronic pancreatitis.\n\n         13. Subject has persistent diarrhea, malabsorption, or known sub-acute bowel obstruction ?\n             NCI CTCAE Grade 2, despite medical management.\n\n         14. Subject has any disorder that may interfere with drug absorption, distribution,\n             metabolism, or excretion (including gastrointestinal surgery and bariatric surgery)\n\n         15. All acute toxic effects of any prior antitumor therapy resolved to Grade ? 1 before\n             the start of study therapy (with the exception of alopecia [Grade 1 or 2 permitted],\n             or neurotoxicity [Grade 1 or 2 permitted], or anemia [Grade 2 permitted])\n\n         16. Subject has any other medical, psychiatric, or social condition, which in the opinion\n             of the investigator, would preclude participation in the study, pose an undue medical\n             hazard, interfere with the conduct of the study, or interfere with interpretation of\n             the study results\n\n         17. Subject has a history of interstitial lung disease, slowly progressive dyspnea and\n             unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary\n             hypersensitivity pneumonitis or multiple allergies. Any lung disease that may\n             interfere with the detection or management of suspected drug-related pulmonary\n             toxicity.\n\n         18. Subject is currently enrolled in any other clinical protocol or investigational trial\n             that involves administration of experimental therapy and/or therapeutic devices, or\n             investigational drug.\n\n         19. Subject has a history of hypersensitivity to RX-3117, gemcitabine, azacytidine\n             cytosine arabinoside, paclitaxel, nab-paclitaxel, or their excipients.\n\n         20. Subject is unwilling or unable to comply with study requirements or planned\n             unavailability for follow-up assessments.Xx_NEWLINE_xXAdministration of another investigational medicinal product within 30 days before the screening period.Xx_NEWLINE_xXThrombolytic use (except to maintain IV catheters) within 10 days prior study treatmentXx_NEWLINE_xXIncreasing corticosteroid dose in 7 days prior to administration of first dose of study drug. Symptomatic patients who have stable or decreasing corticosteroid use in the past 7 days may be includedXx_NEWLINE_xX(Bevacizumab-related exclusion) Current or recent (within 10 days of study enrolment) use of aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or current or recent (within 10 days prior to first dose of bevacizumab) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes Note: The use of full-dose oral or parenteral anticoagulants is NOT permitted for at least two weeks at the time of study enrollment. Prophylactic use of anticoagulants is NOT allowedXx_NEWLINE_xXBlood urea nitrogen (BUN) =< 30 mg/dl within 14 days prior to Step 2 registration andXx_NEWLINE_xXTreatment with any investigational products or with chimeric or fully human monoclonal antibodies within 30 days before randomization, systemic anticancer therapy or radiotherapy within 14 days before randomization (Note: \spot\ radiation for areas of pain is permitted), and major surgery within 14 days before randomization.Xx_NEWLINE_xXPrior therapy wash-out period requirements\r\n* Participants must be at least 4 weeks from prior surgical procedures and surgical incisions must be healed\r\n* Participants must have had their last fraction of external beam radiation therapy at least 4 weeks prior to enrollment; participants with prior radiation therapy must be at least 4 weeks post therapy and have had progression of disease outside the radiation port\r\n* Participants must have had their last dose of cytotoxic chemotherapy at least 28 days prior to enrollment, their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 28 days prior to enrollment, their last dose of a monoclonal antibody at least 28 days prior to enrollment, and their last dose of any investigational agent at least 28 days prior to enrollment\r\n* Participants must have recovered from the acute toxic effects of prior therapy to a grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] v.4.0) level prior to enrollment (does not apply to alopecia)Xx_NEWLINE_xXUse of immune suppressive agents within 30 daysXx_NEWLINE_xXWhole blood transfusion in the last 120 days prior to entry to the studyXx_NEWLINE_xXHas undergone RIC allo BMT: cyclophosphamide (14.5 mg/kg/day) days ?6 and ?5, fludarabine (30 mg/m/day) days ?6 through ?2, total body irradiation (200 cGy) day ?1, day 0 infusion of an unmanipulated bone marrow graft (target 4.0 x 10^8 nucleated cells/kg recipient ideal body\r\nweight), cyclophosphamide (50 mg/kg) days +3 and +4, mycophenolate mofetil days +5 through +35, tacrolimus or sirolimus days +5 through days +180 based on protocol, and filgrastim (5 mcg/kg/day) day +5 through neutrophil recovery (> 1000/uLiter) following Hopkins BMT policy\r\nmanual guidelinesXx_NEWLINE_xXUse of investigational drug, other than the study medications specified by the protocol, within 30 days of transplantationXx_NEWLINE_xXMust agree not to donate sperm from the first dose of study drug to 105 days after the last dose of study drug.Xx_NEWLINE_xXPatients who have had prior exposure to immune checkpoint inhibitors are not eligible; please contact principal investigator, Maria Matsangou at 312-926-4248 for specific questions on potential interactions\r\n* NOTE: Immune checkpoint inhibitors working through OX40 are an exception (for example, MEDI6383, MEDI6469, MEDI0562, oxelumab, and PF-04518600) and are permitted >= 28 days prior to study registrationXx_NEWLINE_xXPrior antitumor therapy as follows, before the first dose of study drug: Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less; Monoclonal antibody treatment for multiple myeloma within 21 days; Cytotoxic therapy within 21 days; Proteasome inhibitor therapy within 14 days; Immunomodulatory agent therapy within 7 days; Radiotherapy within 21 days. However, if the radiation portal covered less than or equal to (<=) 5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapyXx_NEWLINE_xXCurrent or recent (within 10 days of study enrolment) use of aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or current or recent (within 10 days prior to first dose of bevacizumab) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes\r\n* NOTE: The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard of the institution) and the subject has been on a stable dose of anticoagulants for at least two weeks at the time of study enrollment; prophylactic use of anticoagulants is allowedXx_NEWLINE_xXREGISTRATIONXx_NEWLINE_xXAnti-cancer therapy less than 14 days prior to the first dose of study drug (less than 28 days for bevacizumab) or palliative, focal radiation therapy less than 14 days prior to the first dose of study drugXx_NEWLINE_xXAny signs or symptoms of bowel obstruction within 28 days prior to study entryXx_NEWLINE_xXAny of the following clinical laboratory results during screening (i.e., within 28 days before the first dose of study treatment):Xx_NEWLINE_xXNeutrophils (Neuts) >= 1500/uL, within 30 days before study registrationXx_NEWLINE_xXCytotoxic chemotherapy last dose must have been received at least 28 days prior to enrollment, their last dose of biological therapy, immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 7 days prior to enrollment, their last dose of a monoclonal antibody at least 30 days prior to enrollment, and their last dose of any investigational agent at least 30 days prior to enrollmentXx_NEWLINE_xXObtained within 14 days prior to enrollment: bilirubin =< 1.5 mg/dLXx_NEWLINE_xXPresence of brain metastases (unless they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to enrollment provided patient is neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to enrollment)Xx_NEWLINE_xXNeutrophils >= 1500/uL within 14 days prior to first doseXx_NEWLINE_xXIf applicable, stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatmentXx_NEWLINE_xXMust be on stable doses of any drugs affecting hepatic drug metabolism or renal drug excretion (e.g. non-steroidal anti-inflammatory drugs, corticosteroids, barbiturates, diphenylhydantoin, narcotic analgesics, probenecid). Such drugs should not be initiated less than 30 days prior to Baseline/C1D1 or at any time during study participation. Whenever possible, narcotic analgesic doses should be stable within 30 days prior to study entry and during the first cycle of therapy.Xx_NEWLINE_xXAnti-cancer therapy less than 6 weeks prior to the first dose of study drug (less than 28 days for bevacizumab) or palliative, focal radiation therapy less than 14 days prior to the first dose of study drugXx_NEWLINE_xXAND asymptomatic and off systemic corticosteroids and/or enzyme-inducing anti-epileptic medications for brain metastases for >14 days prior to registration.Xx_NEWLINE_xXSubjects taking herbal supplements (St. John's Wort, gingko biloba, etc.) should discontinue these supplements 14 days prior to study registration.Xx_NEWLINE_xXPrior chemotherapy or radiotherapy within 14 days prior to first dose of therapy provided subject has received no growth factor support of any kind within 28 days prior to first dose of therapy, otherwise prior chemotherapy within 28 days prior to first dose of therapyXx_NEWLINE_xXReceived any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine phosphate [fludarabine])Xx_NEWLINE_xXAbnormal clinical laboratory values within 14 days prior to initiation of dosing, as indicated by:Xx_NEWLINE_xXConcurrent anticancer treatment within 28 days before the start of trial treatment (e.g., cytoreductive therapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin); major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy); concurrent systemic therapy with immunosuppressive agents within 28 days before the start of trial treatment; use of hormonal agents within 7 days before the start of trial treatment; or use of any investigational drug within 28 days before the start of trial treatment; Note: subjects receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before the first dose of avelumabXx_NEWLINE_xXObtained within 14 days of randomization: Neutrophils >= 1500/uLXx_NEWLINE_xXAt Screening with a serum sample obtained within 14 days prior to the first study drug administration, andXx_NEWLINE_xXReceived any investigational drugs within the 14 days prior to CIML NK cell infusion dateXx_NEWLINE_xXAnti-cancer therapy less than 14 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drugXx_NEWLINE_xXChemotherapy administration in the 14 days preceding enrollment with the exception of hydroxyurea, which can be continued until through cycle 2; a washout period for oral tyrosine kinase inhibitors (e.g. Jakafi, etc) is not required, although tyrosine kinase inhibitors therapy must be discontinued prior to enrollmentXx_NEWLINE_xXUse of herbal supplements unless discontinued >= 7 days prior to initiation of study drugXx_NEWLINE_xXPatients who have received systemic corticosteroids within 28 days prior to the first dose of study drugXx_NEWLINE_xXPatients who have received systemic nonsteroidal antiinflammatory drug (NSAID) therapy within 14 days prior to the first dose of study drugXx_NEWLINE_xXPrior immunotherapy or chemotherapy is allowed as long as > 14 days prior to enrollmentXx_NEWLINE_xXAt least 14 days must have elapsed since any prior systemic therapy prior to apheresis and prior to the initiation of chemotherapy (including systemic corticosteroids at any dose); systemic anti-malignancy therapy including systemic corticosteroid therapy of any dose is not allowed within 14 days prior to the required leukapheresis\r\n* NOTE: 30 days must elapse from the time of administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the principal investigator (PI) can stimulate immune activity and infusion of CAR T cellsXx_NEWLINE_xXSystemic corticosteroid therapy of any dose is not allowed within 14 days prior to the required leukapheresis, or the initiation of the conditioning chemotherapy regimen; corticosteroid creams, ointments, and eye drops are allowedXx_NEWLINE_xXConcurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc, or chronic administration [> 14 days] of > 20 mg/day of prednisone) within 28 days of the first dose of study drugXx_NEWLINE_xXRecent infection requiring systemic treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXLong-acting somatostatin analogue treatment within 14 days of proposed step 1 start dateXx_NEWLINE_xXSystemic antineoplastic therapy in the past 14 days (excluding hydroxyurea)Xx_NEWLINE_xXReceived any prior monoclonal antibody (except an anti-CD20 antibody) within 90 days before the date of study start.Xx_NEWLINE_xXHospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF (i.e., a vaso-occlusive event cannot be within 14 days prior to signing the ICF)Xx_NEWLINE_xXReceived enzyme-inducing anti-epileptic agents within 14 days of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone)Xx_NEWLINE_xXReceived any of the following prior anticancer therapy:\r\n* Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT); Note: stereotactic radiosurgery (SRS) is allowed\r\n* Non-antiangiogenic therapy (including investigational agents and small molecular kinase inhibitors) within 7 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug\r\n* Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug\r\n* Nitrosoureas or mitomycin C within 42 days or metronomic/protracted low- dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug\r\n* Prior treatment with TVB-2640\r\n* Prior treatment with Carmustine WafersXx_NEWLINE_xXHematocrit (Hct) >= 28% within 30 days of enrollment to studyXx_NEWLINE_xXBlood glucose <1.5 ULN within 30 days of enrollment to studyXx_NEWLINE_xXHistory of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) =< 28 days of study enrollmentXx_NEWLINE_xXPerformed within 14 days (+ 3 working days) prior to registration: Creatinine < 1.5 mg/dLXx_NEWLINE_xXTreatment with any small molecule investigational medicinal product (IMP) within 28 days prior to first doseXx_NEWLINE_xXNon-leukocyte depleted whole blood transfusion within 120 days of the date of patient's start on the studyXx_NEWLINE_xXBe at least 14 days from the last administration of bevacizumabXx_NEWLINE_xXPatients must not have had prior cancer therapy (including biologic, cytotoxic, and experimental therapies, nitrosoureas, and Gliadel wafers or other surgically implantable antitumor treatment) within 21 days of registration; if questions arise, please ask the principal investigator (PI)\r\n* NOTE: Patients must not have Novocure within 24 hours of registrationXx_NEWLINE_xXHormonal tumor therapies should not be administered within 14 days of registration; exceptions may be discussed with the PIXx_NEWLINE_xXHemoglobin >= 8.0 g/dL – may be waived if abnormalities are due to disease related bone marrow involvement, within 14 days of study registration (within 30 days for pulmonary and cardiac assessments)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN, within 14 days of study registration (within 30 days for pulmonary and cardiac assessments)Xx_NEWLINE_xXReceived investigational drugs within the 14 days before 1st dose of study drugXx_NEWLINE_xXChemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.Xx_NEWLINE_xXAllo-HSCT within 90 days of leukapheresisXx_NEWLINE_xXOff antibiotic/antifungal therapy for >/=14 days (Cohort C)Xx_NEWLINE_xXBiologic (anti-neoplastic agent): at least 14 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur; these patients must be discussed with the Study Chair on a case-by-case basisXx_NEWLINE_xXOther clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within 28 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatmentXx_NEWLINE_xXAt least 1 measurable lesion according to modified RECIST Version 1.1 (non?nodal lesions must be ?1.0 cm in the long axis or ?double the slide thickness in the long axis) within 21 days prior to the first dose of study drug.Xx_NEWLINE_xXUse of proton-pump inhibitors within 4 days prior to the first dose of study drug. Other medications that increase gastric pH, ie, histamine H2 receptor antagonists and antacids may be taken provided they are not administered within 2 hours before or after administration of study drug.Xx_NEWLINE_xXUse of any prohibited concomitant medications within 7 days of registrationXx_NEWLINE_xXBlood transfusion within 30 days of consentXx_NEWLINE_xXCT or MRI within 14 days prior of registration; NOTE: participants may be registered if screening CT or MRI is > 14 days of registration if prospective approval is received from overall principal investigator (PI), Dr. Patrick Wen (for prospectively approved circumstances an eligibility exception will not need to be filed)Xx_NEWLINE_xXParticipants who are taking proton pump inhibitors (PPIs) within 7 days of the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drug.Xx_NEWLINE_xXHistory of any of the following within the last 6 months before administration of the first dose of study drug:Xx_NEWLINE_xXReceiving Enzyme Inducing Antiepileptic Drugs (EIAEDs) within 14 days of first dose.Xx_NEWLINE_xXHas used any investigational drug (including marketed drugs not approved for this indication) ? 14 days of C1D1. No time limit applies to the use of marketed drugs approved for this indication provided that the subject has progressed on the treatment and all toxicities attributable to the drug have resolved, returned to baseline or stabilized.Xx_NEWLINE_xXAny form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment excluding steroids; attempts should be made to have patient on lowest possible dose of steroids; these medical entities can be exacerbated by PD-1 blockadeXx_NEWLINE_xXDaily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drugXx_NEWLINE_xXObtained =< 14 days prior to registration: Direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXFOR AML ONLY: Obtained =< 14 days prior to registration: No ANC restrictionXx_NEWLINE_xXFOR TCL ONLY: Obtained =< 14 days prior to registration: ANC >= 1,000/uLXx_NEWLINE_xXFOR TCL ONLY: Obtained =< 14 days prior to registration: PLT >= 100,000/uLXx_NEWLINE_xXRecent infection requiring systemic treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXCELL PROCUREMENT: Subjects currently receiving “maintenance” doses of chemotherapy are eligible and the need for intrathecal prophylaxis prior to procurement is left to the discretion of the investigator; maintenance doses of chemotherapy are defined as methotrexate =< 30 mg/m^2/week, mercaptopurine =< 100 mg/m^2/day and vincristine =< 2 mg/28 days; corticosteroid-containing maintenance therapy is permitted only if corticosteroids are administered > 14 days prior to procurement; (Note: corticosteroid use with doses at the discretion of the treating physician are allowed after procurement up to the beginning of lymphodepletion; corticosteroid use is contraindicated following iC9-CAR19 infusion unless medically necessary e.g., to treat CRS)Xx_NEWLINE_xXRecent infection requiring intravenous anti-infective treatment that was completed =< 14 days before enrollmentXx_NEWLINE_xXUntransfused platelet count >= 75000/mm^3, obtained =< 14 days prior to registrationXx_NEWLINE_xXRadiotherapy =< 14 days prior to registration; NOTE: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXAny of the following prior therapies:\r\n* Cytotoxic chemotherapy =< 14 days prior to registration\r\n* Immunotherapy =< 14 days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< 28 days prior to registration\r\n* Radiation therapy =< 14 days prior to registration\r\n* Targeted therapies (i.e. PARP inhibitors, =< 7 days or 5 half-lives whichever is shorter)\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 14 days prior to registrationXx_NEWLINE_xXSystemic antineoplastic therapy or radiotherapy for other malignant conditions within 14 days before the first dose of any study drug, except for hydroxyureaXx_NEWLINE_xXHas completed prior therapies according to the criteria below:\r\n* Cytotoxic chemotherapy - at least 21 days since last dose prior to first dose of ribociclib\r\n* Small molecule inhibitors - at least 14 days since last dose prior to first dose of ribociclib\r\n* Monoclonal antibodies - at least 3 half-lives since last dose prior to first dose of ribociclib; exception: denosumab for bony metastases is allowable\r\n* Immunotherapy (e.g. tumor vaccines) - at least 42 days since last dose prior to first dose of ribociclib\r\n* Radiation - at least 14 days since last dose prior to first dose of ribociclibXx_NEWLINE_xXConsent to undergo mandatory prostatic core biopsies at the time of fiducial marker placement and 21 days (+/- 7 days) after with or without SD-101 therapy, depending on study armXx_NEWLINE_xXPatient has received other investigational drugs with 14 days before enrollmentXx_NEWLINE_xXMedical indication or subject desire to undergo BC surgery prior to completing at least 14 days of treatment with ODM-201.Xx_NEWLINE_xXConcurrent use of ovarian hormone replacement therapy. Prior treatment should be stopped at least 28 days prior to registration.Xx_NEWLINE_xXUse of other investigational drug within 28 days of enrollment.Xx_NEWLINE_xXReceipt of Investigational agents within 28 days prior to first dose of protocol therapy.Xx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).Xx_NEWLINE_xXWithin 14 days before first dose of avelumab: therapeutic or palliative radiation therapy; (subjects receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before the first dose of avelumab)Xx_NEWLINE_xXVaccination within 28 days of the first dose of avelumab and while on trial is prohibited, except for administration of inactivated vaccines (for example, inactivated influenza vaccine)Xx_NEWLINE_xXAny NSAIDs or omega-3 free fatty acid supplementation within the last 14 daysXx_NEWLINE_xXUse of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up to 4 weeks (28 days) before receiving nivolumabXx_NEWLINE_xXPatients who are taking proton pump inhibitor (PPI) within 7 days before receiving the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drugXx_NEWLINE_xXRadiotherapy within 14 days before randomization; seven days may be considered if to single areaXx_NEWLINE_xXUncontrolled HTN 14 days prior to enrollmentXx_NEWLINE_xXPlatelets (plt) >= 100 x 10^9/L, within 14 days start of study startXx_NEWLINE_xXPrior use of levothyroxineXx_NEWLINE_xXRecent infection requiring systemic treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXAt the time of registration, subject must be removed from prior therapy as follows:\r\n* >= 28 days from any investigational agent,\r\n* >= 4 weeks (28 days) from prior cytotoxic therapy,\r\n* >= 2 weeks (14 days) from vincristine,\r\n* >= 6 weeks (42 days) from nitrosoureas,\r\n* >= 3 weeks (21 days) from procarbazine administration,\r\n* >= 1 week (7 days) for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count)Xx_NEWLINE_xXPatients having undergone recent resection of recurrent or progressive tumor will be eligible given all of the following conditions apply:\r\n* At least 2 weeks (14 days) have elapsed from the date of surgery and the patients have recovered from the effects of surgery\r\n* Evaluable or measurable disease following resection of recurrent malignant glioma is not mandated for eligibility into the study\r\n* To best assess the extent of residual disease post-operatively, a magnetic resonance imaging (MRI) should be done no later than 96 hours in the immediate post-operative period or at least within 4 weeks post-operatively, within 14 days prior to registration; if the 96-hour scan is more than 14 days before registration, the scan needs to be repeated; the patient must have been on a stable steroid dose for at least 5 days prior to the baseline MRI; steroids may be initiated as clinically indicated once baseline imaging has been completed with a goal of titrating steroids as soon as clinically warrantedXx_NEWLINE_xXPatients who received ? 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible.Xx_NEWLINE_xXHas received sorafenib within 14 days of first dose of study medicationXx_NEWLINE_xXAppropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup:\r\n* History/physical examination, documentation of weight and Zubrod performance status 0-2 within 60 days prior to study entry\r\n* Right and left mammography within 90 days of diagnostic biopsy establishing diagnosisXx_NEWLINE_xXNon-study related surgical procedures less than or equal to 14 days prior to CK-101 administrationXx_NEWLINE_xXReceipt of any anti-cancer therapy within 14 days of starting BP1001, with the exception of hydroxyurea or anagrelide, or TKI (within 2 days)Xx_NEWLINE_xXRecent prior chemotherapy:\r\n* Newly diagnosed patients (regardless of group); any prior chemotherapy for POEMS with the following exceptions:\r\n** Prior immunomodulators like azathioprine, cyclosporin, and/or corticosteroids are not exclusionary therapies if used for prior diagnosis of chronic inflammatory demyelinating polyneuropathy\r\n** Prior chemotherapy directed at a “myeloproliferative neoplasm” like hydroxyurea is not exclusionary\r\n* Previously treated patients (group 2)\r\n** Alkylators (e.g. melphalan, cyclophosphamide) =< 28 days prior to registration\r\n** Anthracyclines =< 28 days prior to registration\r\n** High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (e.g. ixazomib or bortezomib) =< 28 days prior to registrationXx_NEWLINE_xXShould be off any active therapy for AML with the exception of hydroxyurea for at least 14 days prior to study registration unless patient has rapidly progressive disease, and all grade 2-4 non-hematologic toxicities should have resolvedXx_NEWLINE_xXTreatment within 14 days prior to first study treatment with conventional therapy or treatment within 28 days prior to first study treatment with an investigational drugXx_NEWLINE_xXPSA blood test within 60 days prior to registrationXx_NEWLINE_xXProstate biopsy with Gleason score and TNM staging within 180 days prior to registrationXx_NEWLINE_xXNo evidence of metastasis on bone scan within 120 days prior to registrationXx_NEWLINE_xXRecent infection requiring systemic treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small (single nodal area), 7 days will be considered a sufficient interval between treatment and beginning of protocol therapyXx_NEWLINE_xXPrior Therapy\r\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n** Cytotoxic chemotherapy (including investigational agents) or biologic agents (eg. cytokines or antibodies): At least 3 weeks after the last dose\r\n** Nitrosoureas/mitomycin C: At least 6 weeks from the last dose\r\n** Radiotherapy (XRT): At least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior traumatic brain injury (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation; e.g. stem cell Infusion without TBI: no evidence of active graft versus (vs.) host disease and at least 56 days must have elapsed after transplant or stem cell infusionXx_NEWLINE_xX=< 28 days post pre-registrationXx_NEWLINE_xXAny of the following therapies prior to registration:\r\n* Chemotherapy =< 21 days\r\n* Immunotherapy =< 21 days\r\n* Biologic therapy =< 21 days\r\n* Hormonal therapy =< 14 days\r\n* Monoclonal antibodies =< 14 days\r\n* Radiation therapy =< 14 days\r\n* Minor surgical or interventional procedure =< 7 days\r\n• Major surgical procedure =< 21 daysXx_NEWLINE_xXReceipt of corticosteroids =< 7 days prior to registration, unless patient has been taking a continuous dose of no more than 15 mg/day of prednisone for at least 30 days prior to registrationXx_NEWLINE_xXHistory/physical examination within 30 days prior to registrationXx_NEWLINE_xXThe ability to interrupt non-steroidal anti-inflammatory drugs NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexedXx_NEWLINE_xXReceipt of any investigational therapy is not permitted within 28 days prior to the first dose of nivolumabXx_NEWLINE_xXPresence of radiologically documented disease; all radiology studies must be performed within 28 days prior to registrationXx_NEWLINE_xXUse of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication.Xx_NEWLINE_xXPrior use of any herbal products known to decrease PSA levels (eg, PC-SPES or saw palmetto) within 30 days prior to the start of study medication.Xx_NEWLINE_xXSerious persistent infection within 14 days prior to the start of study medication.Xx_NEWLINE_xXParticipants must be more than 14 days removed from most recent minor surgical procedure (such as biliary stenting), 28 days from most recent major surgical procedure, 14 days removed from most recent radiation therapy, chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less and 28 days removed from last experimental drug treatment with unpublished or half-life greater than 72 hoursXx_NEWLINE_xXPatients who have received a prior monoclonal antibody =< 28 days prior to study day -14 are not eligibleXx_NEWLINE_xXReceived an allogeneic HCT within the last 100 days; enrollment within 30-100 days after transplant, and after adequate recovery of countsXx_NEWLINE_xXNo prior antineoplastic drug therapy for at least 14 days, with the exception of hydroxyurea, prior to starting OTS167. Patients with rapidly proliferative disease may continue to receive hydroxyurea.Xx_NEWLINE_xXPatients with a diagnosis of advanced CML must have been treated with 3 prior TKIs, and the last therapy must have been discontinued 14 days prior to starting OTS167.Xx_NEWLINE_xXNo prior antineoplastic drug therapy for at least 14 days, with the exception of hydroxyurea, prior to starting OTS167. Patients with rapidly proliferative disease may continue to receive hydroxyurea.Xx_NEWLINE_xXPatients with a diagnosis of advanced CML must have been treated with 3 prior TKIs, and the last therapy must have been discontinued 14 days prior to starting OTS167.Xx_NEWLINE_xXRecent prior therapy, defined as 1. Any non-monoclonal anti-cancer therapy within 14 days or 5 half-lives, whichever is longer, prior to the first dose of GSK3326595. Any nitrosoureas or mitomycin C within 42 days prior to the first dose of GSK3326595. Prior therapy with biologic agents (including monoclonal antibodies) is permitted so long as 28 days have elapsed since therapy and all therapy-related AEs have resolved to =< Grade 1, 2. Any radiotherapy within 14 days or major surgery within 28 days prior to the first dose of GSK3326595. For subjects in the GBM cohort, subjects must have completed radiation therapy at least 28 days prior to the first dose of GSK3326595. 3. Anti-androgen therapies for prostate cancer, such as bicalutamide, must be stopped 4 weeks prior to enrollment. Second-line hormone therapies such as enzalutamide or abiraterone should be stopped 2 weeks prior to enrolment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone [up to 10 milligram (mg)/day] and still be eligible for this study.Xx_NEWLINE_xXReceived any investigational drugs within the 14 days prior to the first day of transplant conditioningXx_NEWLINE_xXReceipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or anagrelide (within 24 hours), TKI (within 1days), or a single dose of cytarabine (for proliferative disease)Xx_NEWLINE_xXTotal bilirubin =< 2mg/dL, obtained within 14 days of first dose of drugXx_NEWLINE_xXPatients who have received other investigational drugs within 14 days prior to screeningXx_NEWLINE_xXAll patients must discontinue anti-platelet agents or anticoagulants 7 days prior to initiation of study drugXx_NEWLINE_xXNo abnormalities on pre-entry electrocardiogram, obtained within 28 days prior to being registered on studyXx_NEWLINE_xXHistory/physical examination within 30 days prior to registrationXx_NEWLINE_xXTaxane therapy within the past 3 months (90 days) prior to study day 1Xx_NEWLINE_xXPatients requiring hydroxyurea to bring WBC below 10,000/uL prior to study enrollment will require a 48-hour washout prior to starting the study drugXx_NEWLINE_xXUse of any other experimental drug or therapy within 21 days of baselineXx_NEWLINE_xXPrior use of other retinoid therapies in the 3 months prior to enrollment in the studyXx_NEWLINE_xXRecent infection requiring systemic treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXRecent infection requiring intravenous anti-infective treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXPatients previously treated with ibrutinib > 14 days are ineligible; if patient has been treated with ibrutinib for < 14 days, it must be discontinued 1 week (7 days) weeks prior to study initiationXx_NEWLINE_xXBody mass index (BMI) >= 35 mg/m^2 =< 56 days prior to registrationXx_NEWLINE_xXUse of thiazolidinedione (TZD) within 28 days prior to enrollmentXx_NEWLINE_xXDaily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drugXx_NEWLINE_xXDaily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drugXx_NEWLINE_xXUse of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up to 4 weeks (28 days) before receiving nivolumabXx_NEWLINE_xXReceipt of any other investigational agents within 14 days prior to study treatmentXx_NEWLINE_xXPatients must be >= 14 days from previous cytotoxic treatmentXx_NEWLINE_xXUse of medications that are known to prolong the QT interval and/or are associated with a risk of torsades de pointes 7 days prior to first doseXx_NEWLINE_xXUse of amiodarone within 90 days prior to first doseXx_NEWLINE_xXTreatment with biologic therapy within 21 days of registration.Xx_NEWLINE_xXThe ability to interrupt nonsteroidal antiinflammatory drug (NSAIDS) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexedXx_NEWLINE_xXPRIOR TO LYMPHODEPLETION: Imaging results from within 30 days prior to enrollment into the main study (used as baseline measure for documentation of progression) before the lymphodepletion; with prior sponsor approval, these results may be obtained at a time point greater than 30 days from lymphodepletion if obtained per the patient’s standard of care and if no other chemotherapy/lymphoma treatment received between most recent scans and start ofXx_NEWLINE_xXAt least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occurXx_NEWLINE_xXBe able to start the drug therapy between 42 to 100 days following allogeneic SCT;\r\n* No more than 1 prior allogeneic SCT\r\n* Post-transplant bone marrow consistent with complete remission with no evidence of minimal residual disease by flow-cytometry or cytogenetics or molecular testing\r\n* Adequate engraftment within 14 days prior to starting study drug: absolute neutrophil count (ANC) >= 1.0 x 10^9/L without daily use of myeloid growth factor; and, platelet >= 50 x 10^9/L without platelet transfusion within 1 weekXx_NEWLINE_xXElectrocardiogram without evidence of acute cardiac ischemia within 14 days prior to study registrationXx_NEWLINE_xXPatients must have the following minimum intervals from prior treatments:\r\n* Surgery – 4 weeks\r\n* Nitrosoureas – 6 weeks\r\n* Cytotoxic chemotherapy – standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose; for drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval\r\n* Investigational therapy or non cytotoxic therapy – 2 weeksXx_NEWLINE_xXAny of the following prior therapies:\r\n* Cytotoxic chemotherapy =<14 days prior to registration\r\n* Immunotherapy =< 14 days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< 14 days prior to registration\r\n* Radiation therapy =<14 days prior to registration\r\n* Targeted therapies (i.e. kinase inhibitors, =< 7 days or 5 half-life’s whichever is shorter)\r\n* For steroids or other non-cytotoxics given for blast count control, patient must be off for > 24 hours (hrs) before starting therapy; NOTE: hydroxyurea (HU) is allowed for blast count control throughout study\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 14 days prior to registrationXx_NEWLINE_xXPatient may have been pretreated with intermediate to high dose cytarabine (more than 1000mg/m2/d over 5d) if the day of the last infusion was at least 90 days before inclusion in the studyXx_NEWLINE_xXPHASE I: A baseline brain MRI must be obtained no more than 14 days (+ 3 working days) prior to study enrollment; the patient must either be on no steroids or a stable dose of dexamethasone no greater than 2 mg a day for at least 5 days prior to entrance onto the study; patients having undergone recent surgery are eligible as long as they are at least 3 weeks from resection or 1 week from stereotactic biopsy, and recovering from any operative or perioperative complications; no measurable disease post resection will be requiredXx_NEWLINE_xXPHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: A baseline brain MRI must be obtained no more than 14 days (+ 3 working days) prior to study enrollment; the patient must either be on no steroids or a stable dose of dexamethasone no greater than 2 mg a day for at least 5 days prior to entrance onto the studyXx_NEWLINE_xXPHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: A baseline brain MRI obtained no more than 14 days (+ 3 working days) prior to study enrollment on a stable dose of steroids no greater than 2 mg a day of dexamethasone for at least 5 days, is required prior to entrance of a patient onto the study; patients must be registered on the study within 5 weeks of completion of concurrent chemoradiationXx_NEWLINE_xXAt least 14 days must have elapsed since any prior systemic therapy prior to apheresis and prior to the initiation of chemotherapy (including systemic corticosteroids at any dose); systemic anti-malignancy therapy including systemic corticosteroid therapy of any dose are not allowed within 14 days prior to the required leukapheresis; NOTE: 60 days must elapse from the time of administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the principal investigator (PI) can stimulate immune activity and infusion of CAR T cellsXx_NEWLINE_xXSystemic corticosteroid steroid therapy of any dose is not allowed within 14 days prior to the required leukapheresis, or the initiation of the conditioning chemotherapy regimen; corticosteroid creams, ointments, and eye drops are allowedXx_NEWLINE_xXUse of medications that are known to prolong the QT interval and/or are associated with a risk of Torsades de Pointes 7 days prior to first doseXx_NEWLINE_xXUse of amiodarone within 90 days prior to first doseXx_NEWLINE_xXMust have started ADT for metastatic disease within 134 days (for Arm A and B) or within 30 days (for Arm C)Xx_NEWLINE_xXReceipt of an investigational agent within 28 days (or 60 days for an antibody-based therapy) before the first planned dose of study drugsXx_NEWLINE_xXPrior frontline therapy for B-CLL must have been discontinued >= 56 days but =< 365 days prior to registration; NOTE: Patients on supportive care therapy due to use of specific induction regimen such as antibiotics may continue on those treatments at the discretion of the treating physicianXx_NEWLINE_xXUse of any other experimental drug or therapy =< 28 days prior to registration on this study; NOTE: Patients on low dose prednisone (=< 10 mg) for treatment of conditions other than CLL are eligibleXx_NEWLINE_xXPatients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days of vaccine treatment\r\n* Note: special considerations for vaccination: study-related treatments may be given after short-term steroid use (=< 4 days) with prior approval by the protocol chair and investigational new drug (IND) sponsorXx_NEWLINE_xXRecipient must not have received any investigational drug within 30 days of starting conditioning treatmentXx_NEWLINE_xXAdequate baseline laboratory values collected within 7 days of starting the study treatmentXx_NEWLINE_xXAbility to interrupt chronic non-steroidal anti-inflammatory drugs (NSAIDs) beginning 2 days before (5 days before for long-acting NSAIDs) and continuing for 2 days following administration of each pemetrexed doseXx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXDaily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drugXx_NEWLINE_xXCompletion of prior systemic therapy at least 14 days prior to enrollmentXx_NEWLINE_xXNeutrophils >= 1500/uL obtained within 14 days prior to randomization/registrationXx_NEWLINE_xXInclusion Critera\n\n          1. Female ? 18 years of age\n\n          2. Histologically proven diagnosis of:\n\n             a. Endometrial and other uterine cancers with tumors of all histologies i. Recurrent\n             Stage I to II endometrial and other uterine cancers, after at least one prior line of\n             standard therapy, requiring further treatment with platinum-based chemotherapy ii.\n             Advanced Stage III to IV endometrial and other uterine cancers requiring treatment\n             with platinum-based chemotherapy b. Ovarian Cancer: Platinum-sensitive or\n             platinum-resistant recurrent or metastatic ovarian, fallopian, or primary peritoneal\n             cancer treated with at least one prior line of platinum-based chemotherapy and\n             requiring further treatment.\n\n             Platinum-sensitive is defined as cancer progression ? 6 months after platinum-based\n             chemotherapy. Platinum-resistant is defined as cancer progression < 6 months after\n             platinum-based chemotherapy.\n\n             Histologic cell types eligible are endometrioid adenocarcinoma, serous adenocarcinoma,\n             undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma,\n             adenocarcinoma not otherwise specified. c. Cervical cancer: recurrent or metastatic\n             cervical cancer that is not amenable to curative treatment with surgery and/or\n             radiation therapy and has not been previously treated with chemotherapy for\n             recurrence.\n\n             Histologic cell types eligible are squamous cell carcinoma, adenosquamous carcinoma or\n             adenocarcinoma\n\n          3. Have measureable disease defined by RECIST 1.1 confirmed by CT or MRI scan within 28\n             days of enrollment.\n\n          4. Life expectancy of ? 3 months at the time of enrollment.\n\n          5. Able to take orally administered study medication.\n\n          6. Have adequate baseline function and performance status within 28 days of enrollment:\n\n               1. Bone marrow function: absolute neutrophil count (ANC) ? 1,500/mm3, platelets ?\n                  100,000/mm3\n\n               2. Renal function: creatinine ? 1.5 x institutional upper limit normal (ULN) or if\n                  creatinine is > 1.5 x ULN, creatinine clearance must be > 50 mL/min.\n\n               3. Hepatic function: bilirubin ? 1.5 x ULN or ? 3.0 x ULN for subjects with Gilbert\n                  Syndrome; AST and ALT ? 3.0 × ULN.\n\n               4. Coagulation profile: international normalized ratio (INR) is ? 1.5 and an aPTT or\n                  PTT < 1.2 x ULN\n\n               5. ECOG performance ? 2\n\n          7. Women of child-bearing potential must agree to use contraceptive measures starting 1\n             week before C1D1 until 4 weeks after the last dose of study treatment and have a\n             negative serum pregnancy test within 28 days of enrollment.\n\n          8. Provide written informed consent and authorization permitting release of Protected\n             Health Information.\n\n          9. Ability and willingness to comply with the study protocol for the duration of the\n             study and with follow-up procedures.\n\n        Exclusion Criteria\n\n          1. Serious, non-healing wound, ulcer or bone fracture.\n\n          2. Major surgical procedure within 28 days or minor surgical procedure performed within 7\n             days prior to C1D1 (a major surgical procedure is defined as requiring general\n             anesthesia).\n\n          3. (Intentionally left blank)\n\n          4. Active bleeding or pathologic conditions that carry high risk of bleeding, such as\n             known bleeding disorder, coagulopathy, or tumor involving major vessels.\n\n          5. History or evidence upon physical examination of central nervous system (CNS) disease\n             including primary brain tumor; seizures not controlled with standard medical therapy;\n             and history of cerebrovascular accident (CVA, stroke), transient ischemic attack\n             (TIA), or subarachnoid hemorrhage within 6 months of enrollment.\n\n             a. Subjects with metastatic CNS tumors may participate in this study if the subject is\n             > 28 days from therapy completion (including radiation and/or surgery), is clinically\n             stable at the time of study enrollment, and is not receiving corticosteroid therapy.\n\n          6. Proteinuria on urinalysis within 28 days of enrollment. Subjects discovered to have a\n             urine protein of 1+ on dipstick or ? 30 mg/dl at baseline should undergo a 24-hour\n             urine collection and demonstrate < 1000 mg protein per 24 hours or spot urine protein\n             (mg/dL) to creatinine (mg/dL) ratio must be <1.0 to allow participation in the study.\n\n          7. Clinically significant cardiovascular disease including uncontrolled hypertension;\n             myocardial infarction or unstable angina within 6 months prior to enrollment; New York\n             Heart Association (NYHA) Grade II or greater congestive heart failure (Appendix E);\n             serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral\n             vascular disease.\n\n          8. Women who are pregnant or nursing.\n\n          9. (Intentionally left blank)\n\n         10. Clinically significant, uncontrolled hypokalemia, hypomagnesaemia, and/or\n             hypocalcaemia.\n\n         11. Hemoptysis within 3 months prior to enrollment.\n\n         12. Acute or chronic liver disease, active hepatitis A or B with known cirrhosis or liver\n             dysfunction.\n\n         13. Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 28 days (42 days in\n             cases of mitomycin C, nitrosourea, lomustine) prior to enrollment.\n\n         14. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19\n             within 14 days prior to enrollment and during the study unless there is an emergent or\n             life-threatening medical condition that required it.\n\n         15. Known history of human immunodeficiency virus infection (HIV).\n\n         16. Active bacterial infections requiring systemic antibiotics (excluding uncomplicated\n             urinary tract infection).\n\n         17. Other invasive malignancies, with the exception of non-melanoma skin cancer, who had\n             (or have) any evidence of other cancer present within the last 5 years prior to\n             enrollment or whose previous cancer treatment contraindicates this protocol therapy.\n\n         18. History of non-malignant gastrointestinal bleeding, gastric stress ulcerations, or\n             peptic ulcer disease within the past 3-months prior to enrollment that in the opinion\n             of the investigator may place the subject at risk of side effects on an\n             anti-angiogenesis product.\n\n         19. History of significant vascular disease (e.g. aortic aneurysm, aortic dissection).\n\n         20. Intra-abdominal abscess within the last 3 months of enrollment.\n\n         21. Pre-existing uncontrolled hypertension as documented by two baseline blood pressure\n             readings taken at least five minutes apart, defined as systolic BP >160 mm Hg or\n             diastolic BP > 90 mm Hg pressure.\n\n         22. QTc > 470 msec on screening ECG per Fridericia's formula.\n\n         23. History of or existing risk factors for Torsades de pointes (TdP) (e.g., heart\n             failure, hypokalemia, family history of Long QT Syndrome).\n\n         24. Concurrent use of concomitant medications that prolong the QT/QTc interval.\n\n         25. Baseline echocardiogram (within 56 days of enrollment) with left ventricular ejection\n             fraction (LVEF) < 50%.\n\n         26. History of difficulty swallowing, malabsorption, active partial or complete bowel\n             obstruction, or other chronic gastrointestinal disease or condition that may hamper\n             compliance and/or absorption of AL3818.\n\n         27. History of pancreatitis; history of renal disease that includes histologically\n             confirmed glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal\n             nephropathy or other renal insufficiencies.\n\n         28. Treatment with an investigational agent within 28 days of enrollment.\n\n         29. Known recreational substance abuse.\n\n         30. Anticoagulation therapy with warfarin. Subjects treated with heparin, low molecular\n             weight heparin, or any other anticoagulant may be included provided the subject has\n             been on a stable therapeutic dose of the anticoagulant for at least 14 days prior to\n             enrollment.\n\n         31. Known hypersensitivity to AL3818 or components of the formulation.Xx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708Xx_NEWLINE_xXThe subject must have recovered from the acute toxic effects of all prior therapy with the exception of alopecia. The following time must have elapsed from the last dose of the following medications to study enrollment:\r\n* Myelosuppressive chemotherapy: 14 days\r\n* Hematopoietic growth factors: 7 days (14 days for Neulasta)\r\n* Biologic agent: 7 days\r\n* Monoclonal antibody: 3 half-lives \r\n* Immunotherapy (ie tumor vaccines): 42 days\r\n* Palliative small port radiation therapy (XRT): 14 days\r\n* Substantial bone marrow XRT: 6 weeks\r\n* Stem cell transplant or infusion without total body irradiation (TBI): 12 weeks\r\n* Total body irradiation (TBI): 24 weeksXx_NEWLINE_xXSubjects with a history of tumor progression within 30 days of anthracycline administration are not eligible. However, subjects who have previously received an anthracycline and subsequently relapse greater than 30 days after their most recent prior dose of anthracycline will be eligible.Xx_NEWLINE_xXSurgery prior to enrollment within 28 days prior to the initiation of study treatment or unhealed surgical incision;Xx_NEWLINE_xXUse of any investigational agents within 30 days prior to enrollment and for the duration of the studyXx_NEWLINE_xXFor subjects on corticosteroids, they must be on a stable dose for 7 days prior to anticipated start of study drugXx_NEWLINE_xXPharmacologic therapy (e.g. statins or ezetimibe) to lower cholesterol within 30 days prior to registration.Xx_NEWLINE_xX5-alpha reductase inhibitors (e.g. finasteride or dutasteride) within 180 days prior to registration.Xx_NEWLINE_xXAdministration of agents with potential QT interval prolonging effects within 14 days prior to the first administration of study drug and while on treatmentXx_NEWLINE_xXHave received NO anti-cancer therapy within 28 days prior to receiving study drugXx_NEWLINE_xXBiologic agents- At least 14 days must have elapsed since the completion of therapy with a biologic agent such as a monoclonal antibody. Seven days must have elapsed since the last dose of retinoidsXx_NEWLINE_xXHematopoietic growth factors- At least 7 days must have elapsed since the last dose of G-CSF or GM-CSF. At least 14 days must have elapsed since last dose of pegfilgrastim (Neulasta®).Xx_NEWLINE_xXPatients who have received wide field radiotherapy ? 28 days (defined as > 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapyXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* X-ray therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n** Note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iodine I 131 metaiodobenzylguanidine [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to selumetinib (AZD6244 hydrogen sulfate)Xx_NEWLINE_xXPost-prostatectomy use of ADT for > 30 days prior to study entry (ADT defined as the use of a GnRH agonist, with or without an anti-androgen)Xx_NEWLINE_xXPrior treatment with immune-modulating agents within 28 days before REGN2810Xx_NEWLINE_xXImmunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to treatment with REGN2810Xx_NEWLINE_xXDaily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drugXx_NEWLINE_xXPatients with recent (within 14 days) or serious ongoing infectionXx_NEWLINE_xXHave laboratory values (obtained ? 28 days prior to first infusion day) in accordance with the study protocolXx_NEWLINE_xXHave received chemotherapy < 21 days prior to C1D1, or < 42 days for mitomycin or nitrosoureas;Xx_NEWLINE_xXHave received targeted small molecule therapy < 14 days prior to C1D1;Xx_NEWLINE_xXImmunotherapy (e.g. tumor vaccine) (At least 42 days since last dose of immunotherapy agent(s) prior to first dose of tazemetostat)Xx_NEWLINE_xXRadiotherapy (RT) (At least 14 days from last local site RT prior to first dose of tazemetostat/At least 21 days from stereostatic radiosurgery prior to first dose of tazemetostat/At least 12 weeks from craniospinal, ?50% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)Xx_NEWLINE_xXHigh dose therapy with autologous hematopoietic cell infusion (At least 60 days from last infusion prior to first dose of tazemetostat)Xx_NEWLINE_xXInclusion Criteria (Escalation and Expansion Phases)\n\n        Patients must meet the following criteria to be eligible to enroll in the study:\n\n          1. Patients must have histologically confirmed solid tumors or hematologic malignancies.\n             Eligible patients include the following:\n\n             a) GIST patients must have a KIT and PDGFRA mutation and must have progressed on or\n             had an intolerability to at least 1 line of systemic anticancer therapy: i. Patients\n             with a pre-existing resistance mutation to an approved line of therapy are eligible.\n             For example, imatinib resistant mutations including KIT Exon 17 and PDGFRA D842V.\n\n             b) SM patients must have a confirmed diagnosis (confirmed by a central independent\n             pathologist) of advanced SM according to 2016 World Health Organization (WHO) criteria\n             for SM and must have documented KIT mutant disease. SM patients must also have a\n             normal karyotype.\n\n             Advanced SM includes: ASM, SM-AHN, wherein the AHN does not require immediate\n             alternative therapy, such as acute myeloid leukemia. AHNs that are eligible include:\n             low grade myelodysplastic syndrome (MDS) with a high SM burden who require treatment\n             for SM only, myeloproliferative neoplasms (MPNs), MDS/MPN, and HES/CEL], and MCL i.\n             Patients with advanced SM must present with at least 1 eligible C-Finding (organ\n             damage) as outlined in Table 3 of the 2013 International Working\n             Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) & European\n             Competence Network on Mastocytosis (ECNM) consensus response criteria (Appendix 10.5);\n             please see below for MCL exception) (#iii).\n\n             ii. Patients with imatinib-sensitive KIT mutations must have progressed on or were\n             intolerant to a tryosine kinase inhibitor.\n\n             iii. Patients with histopathologically-confirmed MCL without a C-finding are eligible.\n\n             iv. Patients with symptomatic SSM are eligible. By definition, SSM patients must have\n             at least 2 B-findings, and clinically significant symptom burden (eg, flushing,\n             diarrhea, etc.) despite maximal treatment with approved agents to treat mediator\n             symptoms, such as antihistamines and cromolyn sodium. Patients must have a normal\n             karyotype.\n\n             v. Patients with hematologic malignancies featuring clonal expansion of eosinophils\n             driven by genomic alterations of KIT or PDGFR (eg, HES or CEL) must have a diagnosis\n             confirmed by a central independent pathologist and are eligible if they have\n             progressed on or are intolerant of imatinib therapy. Patients with de novo imatinib\n             resistant mutations, such as but not limited to KIT D816V or PDGFRA D842V, are\n             eligible without prior imatinib therapy.\n\n             c) Malignant glioma patients with genomic alterations potentially conferring\n             sensitivity to DCC-2618 including, but not limited to, amplification and/or mutations\n             of PDGFRA and/or KIT.\n\n             i. Patients must not require use of enzyme-inducing antiepileptic drugs. ii. Patients\n             that require steroids must be on a stable dose for 2 weeks prior to the first dose of\n             study drug.\n\n             d) Other solid tumor patients that have alterations in genes encoding kinases that are\n             targets of DCC-2618. This includes KIT, PDGFR (A or B), TIE2, CSF1R, and VEGFR2.\n             Patients must have received approved treatments known to provide clinical benefit\n             prior to study entry.\n\n             e) If signs or symptoms suggest CNS metastases, a brain MRI must be performed to\n             confirm absence of CNS disease within 1 week prior to receiving study drug.\n\n          2. Patients with known CNS metastases may participate provided that:\n\n               1. they are stable (ie, without evidence of progression by magnetic resonance\n                  imaging [MRI]) for at least 4 weeks prior to the first dose study drug (patients\n                  with active disease may be eligible following discussion between the Investigator\n                  and the Sponsor),\n\n               2. all neurologic symptoms have been stable for 2 weeks prior to the first dose of\n                  study drug,\n\n               3. patients must not require use of enzyme-inducing antiepileptic drugs,\n\n               4. patients that require steroids must be on a stable dose for 2 weeks prior to the\n                  first dose of study drug.\n\n          3. Patients with solid tumors (with the exception of glial tumors and tumors that are\n             anatomically inaccessible) must have an archival tumor biopsy sample as long as no\n             anticancer therapy was administered since the sample was collected; otherwise, a\n             current biopsy is required. In the case of glial tumors and anatomically inaccessible\n             tumors, the most recent archival tissue is required.\n\n          4. Male or female patients ?18 years of age.\n\n          5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ?2.\n\n          6. Female patients of childbearing potential must have a negative serum beta?human\n             chorionic gonadotropin (?-hCG) pregnancy test within 28 days prior to the start of\n             study drug. For clinical sites in the UK, pregnancy testing must occur within 7 days\n             prior to the start of study drug.\n\n          7. Patients of reproductive potential must agree to follow the contraception requirements\n             outlined in Section 6.8.11.\n\n          8. The patient is capable of understanding and complying with the protocol and has signed\n             the informed consent document. A signed informed consent form must be obtained before\n             any study?specific procedures are performed. Standard procedures performed as part of\n             the practice of medicine prior to consent (eg, imaging, physical exam) can be used to\n             determine eligibility if completed within 28 days prior to the initial dose of study\n             drug.\n\n          9. Patients with solid tumors must have at least 1 measurable lesion according to RECIST\n             Version 1.1 (non-nodal lesions must be ?1.0 cm in the long axis or ?double the slice\n             thickness in the long axis; nodal lesions must be ?1.5 cm in the short axis) or\n             Response Assessment in Neuro-Oncology Criteria (RANO).\n\n             a) A non-brain lesion in a previously irradiated area is eligible to be considered as\n             measurable disease as long as there is objective evidence of progression of the lesion\n             before study enrollment.\n\n         10. Adequate organ function and bone marrow function as indicated by the following central\n             laboratory screening assessments performed within 14 days prior to the first dose of\n             study drug. Local laboratory values obtained after screening and prior to Cycle 1 Day\n             1 dosing that do not meet the criteria below must be discussed with the Sponsor:\n\n               1. Solid Tumor Patients: Bone Marrow Function: Absolute neutrophil count (ANC)\n                  ?1500/?L; hemoglobin ?9 g/dL; platelet count ?75,000/?L.\n\n               2. All Patients:\n\n             i. Hepatic Function: Serum direct bilirubin ?1.5 times the upper limit of normal (ULN)\n             (?3 × ULN if this elevation is solely due to ASM/MCL); aspartate transaminase\n             (AST)/alanine transaminase (ALT), ?3 × ULN (?5 × ULN in the presence of hepatic\n             metastases or if this elevation is solely due to ASM/MCL).\n\n             ii. Renal Function: Serum creatinine ?2.0 × ULN or creatinine clearance ?50 mL/min\n             based either on urine collection or Cockcroft Gault estimation.\n\n             iii. Coagulation Profile: Prothrombin time (PT) - international normalized ratio\n             (INR)/partial thromboplastin time (PTT) ?1.5 × ULN. Patients on a stable, maintenance\n             regimen of anticoagulant therapy for at least 30 days prior to study drug\n             administration may have PT/INR measurements >1.5 × ULN if, in the opinion of the\n             Investigator, the patient is suitable for the study. An adequate rationale must be\n             provided to the Sponsor prior to enrollment.\n\n             c) SM patients with one or more inadequate organ function laboratory value may be\n             eligible if both the Investigator and Sponsor deem it to be disease-related and the\n             abnormality qualifies as a C-Finding (see Appendix 10.5).\n\n         11. Resolution of all toxicities from prior therapy to ?Grade 1 (or baseline) within 1\n             week prior to the first dose of study drug (excluding alopecia and ?Grade 3 clinically\n             asymptomatic lipase, amylase, and creatine phosphokinase laboratory abnormalities).\n\n        Exclusion Criteria (Escalation and Expansion Phases)\n\n        Patients meeting any of the following criteria will be excluded from the study:\n\n          1. GIST patients with wild type or unknown KIT or PDGFRA status.\n\n          2. Patients with SM or other hematologic malignancies will be excluded if the following\n             apply:\n\n               1. SM patients with wild type KIT mutational status.\n\n               2. SM patients with neutropenia accompanied by fever or infection, or\n                  thrombocytopenia associated with clinically significant bleeding.\n\n                    -  Patients with an infection that is well controlled with antibiotics are\n                       eligible if there is an immediate need for treatment\n\n               3. SM-AHN patients diagnosed with:\n\n             i. SM with MDS (SM-MDS) who require treatment for MDS. ii. Patients requiring\n             immediate treatment for AHN. d) Patients with leukemias, with the exception of MCL and\n             CEL, that have progressed after imatinib.\n\n             e) Eosinophilic myeloproliferative neoplasm patients: i. Lacking a mutation that is a\n             known target of DCC-2618. This includes, but is not limited to, fusions/mutations of\n             FGFR1, JAK2, and ABL.\n\n          3. Has a known additional malignancy that is progressing or required active treatment\n             within 3 years of the first dose of study treatment. Exceptions include basal cell\n             carcinoma of the skin, squamous cell carcinoma of the skin that has undergone\n             potentially curative therapy, or other in situ cancers.\n\n          4. Treatment with anticancer therapy, including investigational therapy, within 2 weeks\n             prior to the administration of study drug, with the exception of hydroxyurea that is\n             allowed to control white blood cell count. For prior therapies with a half-life longer\n             than 3 days, the interval must be at least 28 days prior to the first administration\n             of study drug.\n\n          5. New York Heart Association class III and IV heart disease, active ischemia or any\n             other uncontrolled cardiac condition such as angina pectoris, clinically significant\n             cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart\n             failure.\n\n          6. Arterial thrombotic or embolic events such as cerebrovascular accident (including\n             ischemic attacks) or hemoptysis within 6 months before start of study drug.\n\n          7. Venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg,\n             pulmonary embolism) within the 3 months before start of study drug. Patients with\n             venous thrombotic events ?3 months before start of study drug on stable\n             anticoagulation therapy are eligible.\n\n          8. Baseline prolongation of the rate-corrected QT interval based on repeated\n             demonstration of QT interval corrected by Fridericia's formula (QTcF) >450 ms in males\n             or >470 ms in females or history of long QT interval corrected (QTc) syndrome.\n\n          9. LVEF <50% or below the lower limit of normal (whichever is higher).\n\n         10. Major surgery within 4 weeks of the first dose of study drug; following major\n             surgeries >4 weeks prior to the first dose of study drug, all surgical wounds must be\n             healed and free of infection or dehiscence.\n\n         11. Any other clinically significant comorbidities, such as uncontrolled pulmonary\n             disease, active infection, or any other condition, which in the judgment of the\n             Investigator, could compromise compliance with the protocol, interfere with the\n             interpretation of study results, or predispose the patient to safety risks.\n\n         12. Malabsorption syndrome or other illness that could affect oral absorption.\n\n         13. Known human immunodeficiency virus or active hepatitis C infection only if the patient\n             is taking medications that are described in Section 5.8.2.2, active hepatitis B, or\n             active hepatitis C infection.\n\n         14. If female, the patient is pregnant or lactating.\n\n         15. Known allergy or hypersensitivity to any component of the investigational drug\n             product.Xx_NEWLINE_xXReceived interferon, cytarabine, or immunotherapy within 14 days, or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib, or have not recovered (> grade 1 by NCI CTCAE, version 4.0) from AEs (except alopecia), due to agents previously administeredXx_NEWLINE_xXAny major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 28 days prior to enrollment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to enrollmentXx_NEWLINE_xXUse of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study; patients previously treated with v-raf murine sarcoma (RAF) and/or mitogen-activated protein kinase (MEK) inhibitors are excluded from the study; multikinase antiangiogenic tyrosine kinase inhibitors such as regorafenib, sorafenib, sunitinib, etc. whose primary mechanism of action is not RAF inhibition, are allowed; if there are any questions, please contact study's principal investigatorXx_NEWLINE_xXPatients with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollmentXx_NEWLINE_xXAt least 14 days must have elapsed since the completion of therapy with a biologic agent such as a monoclonal antibody; seven days must have elapsed since the last dose of retinoidsXx_NEWLINE_xXA biologic agent (i.e., monoclonal antibodies) for anti-neoplastic intent within 30 daysXx_NEWLINE_xXCAR-T infusion or other cellular therapy within 30 daysXx_NEWLINE_xXWithin 14 days prior to study entry: Platelets (Plt) >= 100 x 10^3/LXx_NEWLINE_xXExpected to undergo HCT within 120 days of enrollmentXx_NEWLINE_xXARM C COHORT 4: Patients who have had decompression of the biliary tree within the last 14 days, must have a stable bilirubin level as confirmed by two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to registration); both the first and second measurement must be =< 2 X IULN; stability is defined as the second measurement being no more than one point higher than the firstXx_NEWLINE_xXPHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or hemoptysis (> 5mL fresh blood within 28 days before study enrollment)Xx_NEWLINE_xXPlatelets > 100000 within 30 days of consentXx_NEWLINE_xXPlatelets > 100000 within 45 days of consentXx_NEWLINE_xXPatients receiving prednisone > 0.5 mg/kg/day at time of enrollment, or have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollmentXx_NEWLINE_xXHistory/physical examination with digital rectal examination of the prostate within 90 days prior to study enrollmentXx_NEWLINE_xXHistory and physical with neurological examination, height, and weight within 14 days prior to registrationXx_NEWLINE_xXComplete blood count (CBC) with differential and a comprehensive metabolic panel (CMP) including liver function tests (LFTs) obtained within 14 days prior to registrationXx_NEWLINE_xXSubject must have at least 2 of the following risk factors\r\n* Pretreatment edema/tumor ratio (>= 35:1) as contoured on a baseline MRI obtained at most 60 days prior to registration; patients are allowed to have whole brain radiotherapy (WBRT) or corticosteroid use between the time of pretreatment MRI and SRS (as long as the corticosteroids can be safely tapered at least 5 days prior to the treatment planning MRI and WBRT is at least 4 days prior to registration)\r\n* Greater than 40 pack year history of smoking cigarettes\r\n* Whole brain radiotherapy at least 4 days and no more than 1 year prior to registration\r\n* Recursive partitioning analysis (RPA) class IIIXx_NEWLINE_xXKnown sulfonylurea treatment within 7 days prior to registration; sulfonylureas include glyburide/glibenclamide (Diabeta, Glynase); glyburide plus metformin (Glucovance); glimepiride (Amaryl); repaglinide (Prandin); nateglinide (Starlix); glipizide (Glucotrol, GlibeneseR, MinodiabR); gliclazide (DiamicronR); tolbutamide (Orinase, Tolinase); and glibornuride (Glutril)Xx_NEWLINE_xXUse of VEGF inhibitors within 10 days prior to registrationXx_NEWLINE_xXPatients receiving an investigational drug within 10 days prior to registrationXx_NEWLINE_xXAny of the following within 6 months prior to study drug administration:Xx_NEWLINE_xXPrevious radioimmunotherapy. Previous antibody-based therapy is allowed as long as ? 28 days has elapsed from last dose to study treatment.Xx_NEWLINE_xXAny non-oncology vaccine therapies used for the prevention of infectious disease within 28 days prior to enrollment and during treatment periodXx_NEWLINE_xXHave received other investigational drugs within 14 days prior to enrollmentXx_NEWLINE_xXADDITIONAL CRITERIA FOR STUDY CONTINUATION: Systemic steroid or immunosuppressive therapy within 14 days before vaccine administrationXx_NEWLINE_xXUse of LHRHA (with or without anti-androgens) for less than 30 days prior to randomisation in the trial.Xx_NEWLINE_xXPatients who have received wide field radiotherapy =< 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapyXx_NEWLINE_xXThrombolytic use (except to maintain i.v. catheters) or anticoagulant use within 10 days prior to first day of study therapyXx_NEWLINE_xXPatients must have evidence of mixed CD3 T-cell chimerism based on the day +28 (+/- 7 days) blood sample showing >= 30% and =< 90% donor type cellsXx_NEWLINE_xXRadiotherapy within 28 days before enrollment; if the involved field is small, 14 days will be considered a sufficient interval between treatment and administration of the therapyXx_NEWLINE_xXAt least 7 days must have elapsed after the last of a biologic agent that is not a monoclonal antibody, to be enrolled on this studyXx_NEWLINE_xXST elevation myocardial infarction within 30 days prior to enrollment; unstable angina or significant, untreated arrhythmias within 30 days prior to enrollmentXx_NEWLINE_xXIf receiving eltrombopag or romiplostim, the dose must have been stable for ? 21 days prior to the first dose of PRTX-100Xx_NEWLINE_xXIf on steroid-sparing adjunctive immunosuppression with cyclosporine, azathioprine, mycophenolate, or 6-mercaptopurine, the dose must have been stable for ? 30 days prior to the first dose of PRTX-100 and must be expected to remain stable through study Day 29, unless dose reduction is required due to toxicities. Treatment with other cytotoxic agents (e.g. cyclophosphamide, vincristine) are not allowed within three months prior to the first dose of PRTX- 100.Xx_NEWLINE_xXSplenectomy ? 90 days prior to the first dose of PRTX-100Xx_NEWLINE_xXEvidence of active infection requiring antibiotic therapy ? 14 days prior to the first dose of PRTX- 100Xx_NEWLINE_xXTreatment with IVIG ? 14 days prior to the first dose of PRTX-100Xx_NEWLINE_xXTreatment with an anti-Rh D antigen agent (e.g. WinPho) ? 14 days prior to the first dose of PRTX-100Xx_NEWLINE_xXNo sooner than 45 days but no later than 90 days after allogeneic HSCT.Xx_NEWLINE_xXPrior therapy:\r\n* Subjects must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n** Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n** Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n** Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines \r\n** Antibodies: > 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade < 1 \r\n** External beam radiation therapy (XRT): at least 14 days after local palliative XRT (small port); 6 weeks must have elapsed since treatment with therapeutic doses of iodine 131-metaiodobenzylguanidine (I131-MIBG); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT, or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n** Stem cell infusion without TBI: no evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant and 42 days for autologous stem cell infusion after I131-MIBG therapy\r\n** Subjects must not have received any prior therapy with simvastatinXx_NEWLINE_xXRadiotherapy within 14 days before randomization; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708Xx_NEWLINE_xXElectrocardiogram (EKG) with QTcB (Bazett’s formula) > 480 ms done within 14 days of enrollmentXx_NEWLINE_xXAdequate baseline laboratory values collected no more than 7 days before starting study treatmentXx_NEWLINE_xXReceipt of monoamine oxidase inhibitors (MAOIs) within 21 days before first dose of study treatmentXx_NEWLINE_xXThe date protocol therapy is projected to start must be no later than 7 days after the date of study registrationXx_NEWLINE_xXPatient has received other investigational drugs with 14 days before enrollmentXx_NEWLINE_xXAt least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).Xx_NEWLINE_xXAt least 7 days after the last dose of a biologic agent.Xx_NEWLINE_xXAt least 14 days after local palliative XRT (small port); At least 150 days must have elapsed if prior TBI, craniospinal XRT or if ? 50% radiation of pelvis; At least 42 days must have elapsed if other substantial bone marrow radiation.Xx_NEWLINE_xXPatients must have a complete history and physical examination within 30 days prior to registrationXx_NEWLINE_xXReceived any investigational compound within 28 days prior to the first dose of study drug or planned during the treatment period or follow-upXx_NEWLINE_xXA complete blood count and differential must be obtained within 21 days prior to radiation fraction 1Xx_NEWLINE_xXBiologic (anti-neoplastic agent): at least 7 days must have elapsed since the completion of therapy with other biologic agents; for other biologic agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chairXx_NEWLINE_xXMale subjects must not donate sperm from initial study drug administration, until 90 days after drug discontinuation.Xx_NEWLINE_xXEXCLUSION CRITERIA FOR ENROLLMENT: The use of immunosuppression for grade II-IV acute GVHD within 28 days prior to the infusion of PTCy-MILsXx_NEWLINE_xXDemonstrate adequate organ function, screening labs that include hematology and chemistry labs should be performed within 14 days of registration on the studyXx_NEWLINE_xXPatients who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within 28 days prior to initial administration of drugXx_NEWLINE_xXPatients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within 28 days prior to initial administration of drugXx_NEWLINE_xXIf the patient has been treated with non-steroidal anti-androgens (flutamide, bicalutamide or nilutamide) or other hormonal treatment (such as ketoconazole), these agents must have been stopped at least 28 days prior to enrollment for flutamide or ketoconazole, and at least 42 days prior to enrollment for bicalutamide or nilutamide; and the patients must have demonstrated progression of disease since the agents were suspendedXx_NEWLINE_xXPatients on antiplatelet/anticoagulant medication that cannot safely be discontinued 5-7 days prior to the procedureXx_NEWLINE_xXWhite blood cell count > 50,000 per micro liter (/µL); hydroxyurea may be used to control the level of circulating leukemic blast cell counts prior to study entry and, if needed, concomitantly while on TAK-659 treatment during the first 28 days of the study. Hydroxyurea can be used up to a maximum dose of 5 gram per (g/) day.Xx_NEWLINE_xXReceived any therapies intended to treat malignancy within 14 days of first receipt of DS-3032b (except for hydroxyurea, which must be discontinued at least 48 hours prior to study treatment).Xx_NEWLINE_xXConfirmation by a surgeon that the patient is able to undergo a low anterior resection with total mesorectal excision =< 28 days prior to registrationXx_NEWLINE_xXUse of any other experimental drug or therapy within 14 days of baselineXx_NEWLINE_xXUse of any investigational drugs within 30 days prior to dosingXx_NEWLINE_xXPatients who have received donor lymphocyte infusion (DLI) within 28 days of Viralym-A infusion.Xx_NEWLINE_xXPatients who have received other investigational drugs within 28 days of Viralym-A infusion.Xx_NEWLINE_xXGastrointestinal (GI) bleed within 30 days prior to registration on studyXx_NEWLINE_xXCurrent use of certain medications: (1) smoking cessation meds (last 7 days), i.e., Wellbutrin, Bupropion, Zyban, nicotine replacement therapy (NRT), Chantix, (2) certain medications to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (Amitriptyline), (3) a case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however pro re nata (PRN) use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month’s duration)Xx_NEWLINE_xXWithin 30 days of registration: patients must have vital signs, history/physical examination, laboratory studies (complete blood count panel [CBCP] with differential, chemistries including liver function tests, creatinine clearance [CrCl] assessment; pregnancy test if needed within 14 days of registration)Xx_NEWLINE_xXReceived wide field radiotherapy =< 28 days or limited field radiation for palliation =< 14 days prior to registration or who have not recovered from side effects of such therapyXx_NEWLINE_xXPatients are eligible for enrollment if they have not had prior investigational or approved cytotoxic chemotherapy within 28 days prior to the first dose (week 1, day 1); 42 days in the case of alkylating agents; 28 days or 5 half-lives (whichever is less; but not less than 14 days) in case of investigational or approved molecularly targeted agent; 14 days in the case of radiotherapy; any number of prior therapies is allowableXx_NEWLINE_xXInterested in quitting smoking in the next 30 daysXx_NEWLINE_xXPatients receiving prednisone > 0.5 mg/kg/day at time of enrollment, or have received anti-thymocyte globulin (ATG), donor lymphocyte infusion (DLI) or Campath within 28 days of enrollmentXx_NEWLINE_xXPatients that previously were treated with ibrutinib for > 7 daysXx_NEWLINE_xXPatient has received other investigational drugs within 14 days before enrollmentXx_NEWLINE_xXPatient must have a history/physical examination with digital rectal examination of the prostate within 90 days prior to screeningXx_NEWLINE_xXUse of finasteride within 30 days prior to registration; PSA should not be obtained prior to 30 days after stopping finasterideXx_NEWLINE_xXUse of dutasteride within 90 days prior to registration; PSA should not be obtained prior to 90 days after stopping dutasterideXx_NEWLINE_xXPatients who are taking proton pump inhibitor (PPI) within 7 days before receiving the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drugXx_NEWLINE_xXPatients must be at least 28 days post systemic steroids prior to enrollmentXx_NEWLINE_xXWithin 30 days of first vaccination: Blood glucose < 1.5 ULNXx_NEWLINE_xXBiologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Study Chair.Xx_NEWLINE_xXPatients must not have received other investigational agents within 14 days of initiation of the conditioning regimenXx_NEWLINE_xXThe following laboratory values must be documented within 3 days prior to the first dose of study drug:Xx_NEWLINE_xXAny major surgery, extensive radiotherapy (> 15 days of treatment), chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to first dose of study treatment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to first dose of study treatmentXx_NEWLINE_xXPatients must not have taken nonsteroidal anti-inflammatory drugs (NSAID) in the past 14 days before treatment on this protocolXx_NEWLINE_xXHistory/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registrationXx_NEWLINE_xXBaseline serum PSA value performed with an Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registrationXx_NEWLINE_xXStudy entry PSA should not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasterideXx_NEWLINE_xXUse of finasteride within 30 days prior to registrationXx_NEWLINE_xXUse of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registrationXx_NEWLINE_xXAt the time of treatment on protocol patients must have recovered from the toxic effects of prior therapy: > 10 days from any noncytotoxic investigational agent, > 28 days from prior cytotoxic therapy or Avastin, > 14 days from vincristine, > 42 days from nitrosoureas, > 21 days from procarbazine administration, and > 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count); any questions related to the definition of non-cytotoxic agents should be directed to the study chairXx_NEWLINE_xXPatients on nonsteroidal anti-inflammatory drugs (NSAIDs) will be eligible only when they are off NSAIDs for 14 daysXx_NEWLINE_xXPatients must be on stable dose of steroids for at least 5 days prior to baseline imagingXx_NEWLINE_xXHistory/physical examination with digital rectal examination of the prostate within 90 days prior to registrationXx_NEWLINE_xXHistory and physical including neurological exam, height, weight, cranial skin exam, and Karnofsky performance status >= 70% within 30 days prior to registrationXx_NEWLINE_xXWithin 14 days prior to registration: Blood urea nitrogen (BUN) and creatinine (Cr) < 2 x ULNXx_NEWLINE_xXThe subject has received any of the following prior anticancer therapy:\r\n* Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site\r\n* Radiation therapy within 12 weeks of screening\r\n* Systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (e.g., tamoxifen) within 14 days or 5 half-lives, whichever is shorter, prior first dose of study drug\r\n* Biologic agents (antibodies, immune modulators, vaccines, and cytokines) within 21 days prior to first dose of study drug\r\n* Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug\r\n* Prior treatment with carmustine wafers\r\n* Patients who are currently receiving any other investigational agents and/or who have received an investigational agent in the prior 28 daysXx_NEWLINE_xXLVEF < 50% and >= 40% documented in echocardiogram done within the last 30 daysXx_NEWLINE_xXReceived any investigational drugs within the 14 days prior to the first dose of fludarabineXx_NEWLINE_xXPatients who have received prior anti-cancer treatment within the following time frames:\r\n* Received systemic therapies less than 14 days prior to starting on treatment\r\n* Received radiation therapy less than 14 days prior to starting on treatment\r\n* Received biologic therapy less than 14 days prior to starting on treatmentXx_NEWLINE_xXPrevious treatment with any substrate of CYP2B6 enzyme < 14 days prior to initiation of investigational productsXx_NEWLINE_xXAt least 7 days should have elapsed since the completion of therapy with a biologic agentXx_NEWLINE_xXUse of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before treatmentXx_NEWLINE_xXHistory and physical with neurological examination, steroid documentation, height, and weight within 14 days of registrationXx_NEWLINE_xXSystemic immunosuppressive therapy in the past 14 daysXx_NEWLINE_xXFor the MF and MDS/MPN-U arms (arms 1 & 2), use of any other standard drug (except hydroxyurea, anagrelide, growth factors, Revlimid, clofarabine, etc) or experimental drug or therapy within 14 days of starting study therapyXx_NEWLINE_xXReceipt of posaconazole or voriconazole as empirical treatment for this infection for 4 days (96 hours) or more within the 15 days immediately before randomization.Xx_NEWLINE_xXUse of any other experimental drug or therapy within 21 days of study-related drug therapyXx_NEWLINE_xXExposure to any prior chemotherapy or steroid use within 14 days of study-related drug therapy; (steroid use is allowed if necessary to treat spinal cord compression)Xx_NEWLINE_xXMust not have myelofibrosis or other disease known to prolong neutrophil engraftment to > 28 days after transplantXx_NEWLINE_xXMelanoma specific systemic therapy within 30 days of enrollmentXx_NEWLINE_xXSystemic immunoglobulin therapy within the last 30 daysXx_NEWLINE_xXPregnancy testing will be performed within 14 days prior to treatment (Turnstile II)Xx_NEWLINE_xXExpected survival if untreated of > 90 daysXx_NEWLINE_xXInitiation of hormonal agent (such as tamoxifen, anastrazole, or letrozole) in the 30 days before treatment; patients who have been on a hormonal agent for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on this hormonal agent for the duration of the studyXx_NEWLINE_xXInitiation of immunotherapy (such as trastuzumab-Herceptin) in the 30 days before treatment; patients who have been on trastuzumab for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on trastuzumab for the duration of the studyXx_NEWLINE_xXDiscontinuation of anti-coagulants and anti-platelet drugs at least 7 days prior to start of study drug; aspirin 81 mg is permitted as long as platelet count is > 50 and there is no evidence of active bleeding or coagulopathy (INR > 1.5, fibrinogen > 150)Xx_NEWLINE_xXPatients must be between 100 to 180 days after ASCTXx_NEWLINE_xXConcomitant medications, if taken within the last 28 daysXx_NEWLINE_xXErythropoietin or related hormones must not have been administered within the past 28 daysXx_NEWLINE_xXFemale subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drugXx_NEWLINE_xXPatients must either not be receiving steroids, or be on a stable dose of steroids for at least five days prior to registrationXx_NEWLINE_xXPatients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:\r\n* They have recovered from the effects of surgery and be > 3 weeks from surgery\r\n* Residual disease following resection of recurrent malignant glioma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to registration; if the 96-hour scan is more than 14 days before registration, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 daysXx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of baselineXx_NEWLINE_xXPatient must have received last dose of known myelosuppressive chemotherapy > 21 days prior to enrollment; > 42 days if nitrosureaXx_NEWLINE_xXBiologic agent - must have recovered from any acute toxicity potentially related to the agent and received their last dose of the biologic agent > 7 days prior to study enrollment\r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occurXx_NEWLINE_xXImmunomodulatory treatment - patient must have received last dose > 21 days prior to enrollmentXx_NEWLINE_xXPatients must have had their last fraction of: \r\n* Craniospinal irradiation (> 24 Gy) > 3 months prior to enrollment\r\n* Focal irradiation > 42 days prior to enrollment\r\n* Local palliative irradiation (small port) > 14 daysXx_NEWLINE_xXIf patient is on corticosteroids, the dose must be stable or decreasing for at least 5 days prior to enrollmentXx_NEWLINE_xXMust not donate sperm starting at screening throughout the study period and for 90 days after the final study drug administration.Xx_NEWLINE_xXReceived systemic anticancer therapy (including cytotoxic chemotherapy, investigational agent, antineoplastic monoclonal antibodies, or immunotherapy) ?14 days prior to first dose of AP32788 (except for reversible EGFR TKIs [ie, erlotinib or gefitinib], which are allowed up to 7 days prior to the first dose of AP32788).Xx_NEWLINE_xXInclusion Criteria:\n\n          1. Patients must have a histologically confirmed diagnosis of malignant PEComa that is\n             either metastatic or locally advanced and for which surgery is not a recommended\n             option.\n\n          2. Patients must have available tumor block along with the corresponding pathology report\n             (or approximately 30 unstained slides, with a minimum of 16 slides), and/or fresh\n             biopsy to allow retrospective centralized confirmation of malignant PEComa and for\n             mTOR pathway analysis and biomarker analysis.\n\n          3. Patients must have one or more measurable target lesions by CT scan or MRI. Measurable\n             disease by RECIST v1.1.\n\n          4. Patients must not have been previously treated with an mTOR inhibitor.\n\n          5. Prior treatment (investigational or other), chemotherapy, radiotherapy, surgery, or\n             other therapeutic agents (except mTOR inhibitors) is allowed, if completed after 5\n             half-lives or ?28 days prior to enrollment, whichever is shorter.\n\n          6. Eligible patients, 18 years or older, with Eastern Cooperative Oncology Group (ECOG)\n             performance status 0 or 1.\n\n          7. Patients must have the following blood chemistry levels at screening (obtained\n\n             ?14 days prior to enrollment (local laboratory):\n\n               1. total bilirubin ?1.5 x upper limit of normal (ULN) mg/dl\n\n               2. AST ?2.5 x ULN (?5 x ULN if attributable to liver metastases)\n\n               3. serum creatinine ?1.5 x ULN\n\n          8. Adequate biological parameters as demonstrated by the following blood counts at\n             screening (obtained ?14 days prior to enrollment, local laboratory):\n\n               1. Absolute neutrophil count (ANC) ?1.5 × 109/L;\n\n               2. Platelet count ?100,000/mm3 (100 × 109/L);\n\n               3. Hemoglobin ?9 g/dL.\n\n          9. Serum triglyceride <300 mg/dL; serum cholesterol < 350 mg/dL.\n\n         10. Male or non-pregnant and non-breast feeding female:\n\n               -  Females of child-bearing potential must agree to use effective contraception\n                  without interruption from 28 days prior to starting IP and while on study\n                  medication and have a negative serum pregnancy test (? -hCG) result at screening\n                  and agree to ongoing pregnancy testing during the course of the study, and after\n                  the end of study treatment.\n\n               -  Male patients must practice abstinence or agree to use a condom during sexual\n                  contact with a pregnant female or a female of childbearing potential while\n                  participating in the study, even if he has undergone a successful vasectomy.\n\n         11. Life expectancy of >3 months, as determined by the investigator.\n\n         12. Ability to understand and sign informed consent.\n\n         13. Willingness and ability to comply with scheduled visits, laboratory tests, and other\n             study procedures.\n\n        Exclusion Criteria:\n\n        A patient will not be eligible for inclusion in this study if any of the following criteria\n        apply:\n\n          1. Patients with lymphangioleiomyomatosis (LAM) are excluded.\n\n          2. Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A\n             patient with controlled and asymptomatic CNS metastases may participate in this study.\n             As such, the patient must have completed any prior treatment for CNS metastases ?28\n             days (including radiotherapy and/or surgery) prior to start of treatment in this study\n             and should not be receiving chronic corticosteroid therapy for the CNS metastases.\n\n          3. Active gastrointestinal bleeding, if transfusion dependent.\n\n          4. Pre-existing thyroid abnormality is allowed provided thyroid function can be\n             controlled with medication.\n\n          5. Uncontrolled serious medical or psychiatric illness. Patients with a \currently\n             active\ second malignancy other than non-melanoma skin cancers, carcinoma in situ of\n             the cervix, resected incidental prostate cancer (staged pT2 with Gleason Score ? 6 and\n             postoperative PSA <0.5 ng/mL), or other adequately treated carcinoma-in-situ are\n             ineligible. Patients are not considered to have a \currently active\ malignancy if\n             they have completed therapy and are free of disease for ?1 year).\n\n          6. Liver-directed therapy within 2 months of enrollment. Prior treatment with\n             radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial\n             embolization (with or without chemotherapy) or cyrotherapy/ablation) is allowed if\n             these therapies did not affect the areas of measurable disease being used for this\n             protocol.\n\n          7. Recent infection requiring systemic anti-infective treatment that was completed\n\n             ?14 days prior to enrollment (with the exception of uncomplicated urinary tract\n             infection or upper respiratory tract infection).\n\n          8. Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy.\n\n          9. Unstable coronary artery disease or myocardial infarction during preceding 6 months.\n\n         10. Receiving any concomitant antitumor therapy.\n\n         11. Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary\n             hypertension.\n\n         12. The use of certain medications and illicit drugs within 5 half-lives or 28 days,\n             whichever is shorter prior to the first dose of study drug and for the duration of the\n             study will not be allowed.\n\n         13. Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving\n             the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with\n             narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride,\n             dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to\n             receiving the first dose of ABI-009.Xx_NEWLINE_xXObtained =< 28 days prior to randomization:\r\nHemoglobin > 9.0 g/dLXx_NEWLINE_xXRecent infection requiring systemic treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXUGT1A1 genotype other than *1/*1, *1/*28, or *28/*28Xx_NEWLINE_xXUnable or unwilling to discontinue (and substitute if necessary) use of prohibited drugs for at least 14 days (fruits and juices for at least 7 days) prior to day 1 of FOLFIRI + bevacizumab initiationXx_NEWLINE_xXHistory/physical examination within 42 days prior to registration to document cervical tumor size and stageXx_NEWLINE_xXPatient must not have received: CYP3A4 inducers within fourteen (14) days prior to registration and for the duration of the studyXx_NEWLINE_xXPatient must begin therapy within 7 calendar days of registrationXx_NEWLINE_xXBaseline serum PSA value performed with a Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registrationXx_NEWLINE_xXBaseline serum testosterone obtained within 60 days prior to registrationXx_NEWLINE_xXA MRI of the spine is required within 10 days prior to or at least 10 days after surgeryXx_NEWLINE_xXSerum HCGB and AFP levels must be assessed within 7 days prior to registrationXx_NEWLINE_xXPatient must have lumbar CSF for cytology, protein, AFP and HCGB within 7 days prior to registrationXx_NEWLINE_xXMust not have received any biological modifier within 14 days of entry on to this studyXx_NEWLINE_xXLiver function test must be obtained within 14 days prior to registrationXx_NEWLINE_xXInclusion Criteria (Parts B & C):\n\n          -  18 years or older\n\n          -  Histologically confirmed unresectable Stage III or Stage IV malignant melanoma, or\n             other solid tumor malignancies\n\n          -  Failed to respond to or relapsed following standard treatment, declined or was not\n             eligible for standard treatment.\n\n          -  Expected survival of at least 12 weeks.\n\n          -  Eastern Cooperative Oncology Group performance status score of 0 or 1 is required.\n\n          -  Evidence of adequate organ function by standard laboratory tests.\n\n        Exclusion Criteria (Parts B & C):\n\n          -  Evidence of progression of central nervous system (CNS) metastases or symptomatic CNS\n             metastases within 35 days prior to dosing.\n\n          -  Ocular melanoma which has not metastasized or presence of a non-solid tumor.\n\n          -  A history of any major surgery within 4 weeks prior to dosing.\n\n          -  Any history of antitumor therapy completed within 28 days prior to dosing.\n\n          -  Subjects with active autoimmune disease or history of known or suspected autoimmune\n             disease, with the exception of subjects with isolated vitiligo, resolved childhood\n             asthma/atopy, psoriasis not requiring systemic treatment and controlled thyroid\n             disorders.\n\n          -  Clinically significant heart disease, defined as NYHA Class III or IV.\n\n          -  Any significant systemic infection requiring IV antibiotics.\n\n          -  Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface\n             antigen (HBsAg), or hepatitis C antibodies (HCAb) unless HCV RNA undetected/negative.\n\n          -  Treatment with any other anti-human GITR monoclonal antibody (mAb) or immunomodulatory\n             therapy 42 days prior to dosing (30 days for Interleukin-2 & Interferon-?, 7 days for\n             Topical Imiquimod).\n\n          -  Adverse events from prior anti-cancer therapy that have not resolved to grade ?1\n             except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy.\n\n          -  Use of any investigational drugs within 30 days prior to dosing.\n\n          -  Any condition that requires or is likely to require treatment with pharmacologic doses\n             of systemic corticosteroids. Subjects are permitted to receive physiologic replacement\n             of corticosteroid therapy (? 10 mg prednisone daily).Xx_NEWLINE_xXPre-treatment tests must be performed within 30 days prior to enrollmentXx_NEWLINE_xXThe date protocol therapy is projected to start must be no later than 7 days after the date of study registrationXx_NEWLINE_xXReceived the last anti-cancer therapy at least 28 days agoXx_NEWLINE_xXSystemic steroid therapy within 28 days before vaccine administrationXx_NEWLINE_xXAnticipated need for systemic steroid therapy within 28 days after vaccine administrationXx_NEWLINE_xXPrior Therapy: therapy with monoclonal antibodies and/or chemotherapy must be stopped at least 14 days prior to anti-CD19 CAR-transduced T cell infusion, and recovery of treatment-associated toxicity to =< grade 2 is required prior to infusion of cells; for patients that have received prior DCI, the last dose must be at least 28 days prior to anti- CD19 CAR-transduced T cell administration; note that patients can be enrolled on this study at any time after or during therapy, but at least 14 days must elapse from the time of prior monoclonal antibody administration or chemotherapy until anti-CD19 CAR-transduced T cells are infused, and at least 28 days must elapse from the time of withdraw of immunosuppression, or DCI, or other immunomodulatory therapies such as lenalidomide until anti-CD19 CAR-transduced T cells are infused; systemic immunosuppression must be stopped at least 28 days prior to protocol entry; there is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of suchXx_NEWLINE_xXUse of any other experimental drug or therapy =< 28 days prior to registrationXx_NEWLINE_xXMyelosuppressive chemotherapy: must not have received within 28 days of entry onto this study (42 days if prior nitrosourea drug) accompanied by hematopoietic recovery or 14 days of stopping non-myelosuppressive therapy as long as hematopoietic requirements are metXx_NEWLINE_xXBiologic (anti-neoplastic agent): must not have received within 7 days of entry onto this study (21 days if prior vascular endothelial growth factor (VEGF)-trap and at least 3 half-lives after last dose of a monoclonal antibody); for biologic agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occurXx_NEWLINE_xXSubjects whose physicians determine that anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) cannot be safely discontinued from 2 days prior to being administered HSV1716 to 28 days following administration should not be in the studyXx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of baseline.Xx_NEWLINE_xXWBC > 2.5 x 10^9/L with an ANC > 1.5 x 10^9/L and off G-CSF for 3 daysXx_NEWLINE_xXSubjects must have had prior treatment with temozolomide; at least 28 days must have elapsed since completion of temozolomide or other chemotherapyXx_NEWLINE_xXUnexplained temperature > 38.5° C for any 7 consecutive days or chronic diarrhea defined as > 3 stools/day persisting for 15 consecutive days, within the 30 days prior to randomization.Xx_NEWLINE_xXInclusion Criteria:\n\n        Patients must meet all the following inclusion criteria to be eligible for enrollment into\n        the study:\n\n          1. Age ? 18 years;\n\n          2. Life expectancy > 12 weeks;\n\n          3. Present with histologically confirmed intracranial (supratentorial) unmethylated MGMT\n             promotor status GBM (WHO Grade lV astrocytoma) with a MGMT status that has been\n             confirmed by validated PCR or validated alternate genomic analysis;\n\n          4. Have undergone maximal surgical resection of their tumor and within 6 weeks of surgery\n             received initial treatment with XRT/TMZ which consisted of XRT by external beam to a\n             partial brain field in daily fractions of 2.0 Gray (Gy), to a planned total dose to\n             the tumor of 60.0 Gy, in conjunction with TMZ oral QD 75 mg/m2 in accordance with the\n             Stupp regimen;\n\n          5. Must have measurable disease, according to RANO criteria for inclusion in the\n             expansion cohort. Patients with non-measurable disease can be included in the\n             dose-escalation cohorts;\n\n          6. KPS ? 70;\n\n          7. Cranial magnetic resonance imaging (MRI) must have been performed within 7 days prior\n             to or on the day of the Randomization/Week 1 Visit;\n\n          8. Stable or decreasing corticosteroid dose within 7 days prior to the first dose;\n\n          9. Adequate bone marrow/hematological function within 7 days prior to Day 1;\n\n         10. Adequate liver and renal function within 14 days prior to Day 1;\n\n         11. International normalized ratio (INR) or prothrombin time (PT) (secs) and activated\n             partial thromboplastin time (aPTT) within 7 days prior to randomization:\n\n         12. Patients must be willing to forego other drug therapy against the tumor while enrolled\n             in the study.\n\n        Exclusion Criteria:\n\n          1. Previous radiotherapy to the brain or cytotoxic drug therapy (including Gliadel®\n             wafers) in addition to the required postoperative radiation plus TMZ, non-cytotoxic\n             drug therapy, or experimental drug therapy directed against the brain tumor prior to\n             this regimen, will be excluded. Patients may have received or be receiving\n             corticosteroids, analgesics, and other drugs to treat symptoms or prevent\n             complications but the dose must be stable at treatment start. NOTE: 5 aminolevulinic\n             acid-mediated photodynamic therapy administered prior to surgery to aid in optimal\n             surgical resection is not considered a chemotherapy agent;\n\n          2. Any prior or anticipated concomitant treatment involving a medical device (such as\n             Optune®) applying tumor treating fields (TTF);\n\n          3. QT interval time of ? 470 msec;\n\n          4. Undetermined/indeterminate MGMT status;\n\n          5. Diabetic patients; prediabetic patients treated with metformin;\n\n          6. Use of any CYP3A4 inducing or inhibiting agents;\n\n          7. Significant medical illnesses;\n\n          8. Women who are pregnant or who are lactating;\n\n          9. Diagnosed with infratentorial GBM, a tumor outside of brain or gliomatosis cerebri;\n\n         10. Evidence of recent hemorrhage on postoperative MRI of the brain;\n\n         11. Any previous malignancy; except for adequately controlled limited basal cell carcinoma\n             of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix, or one\n             which has been absent for ?3 years;Xx_NEWLINE_xXSubject has received other investigational agents or devices within 28 days prior to first dose of study treatment.Xx_NEWLINE_xXPrior treatment with the following agents: a) Tumor necrosis factor receptor (TNFR) agonists, including OX40, cluster of differentiation (CD)27, CD137 (4-1BB), CD357 (glucocorticoid-induced TNFR family-related gene) at any time. b) TLR4 agonist at any time. c) Anticancer therapy or investigational therapy within 30 days or 5 half-lives of the drug, whichever is shorter. d) Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 14 days before start of study treatment for radiation of any intended use to the extremities for bone metastases and 28 days for radiation to the chest, brain, or visceral organs is required.Xx_NEWLINE_xXLaparoscopic procedure or open biopsy within 7 days prior to study drug administrationXx_NEWLINE_xXFine needle aspirate within 3 days prior to study drug administrationXx_NEWLINE_xXPlatelet count >= 75000/mm^3, obtained =< 14 days prior to registrationXx_NEWLINE_xXLoco-regional therapy to the liver within 28 days before randomizationXx_NEWLINE_xXObtained =< 14 days prior to registration: Un-transfused platelet count >= 75000/uL (>= 50,000/uL if marrow plasma cells [PC]% > 50%)Xx_NEWLINE_xXRadiotherapy =< 14 days prior to registration; Note: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXMain criteria for inclusion:\n\n        PK Phase:\n\n        To be considered eligible to participate in this study, all of the following requirements\n        must be met:\n\n          -  Patients with histologically or cytologically confirmed diagnosis of metastatic or\n             locally advanced solid tumors that have failed to respond to standard therapy, has\n             progressed despite standard therapy, or for which no standard therapy exists, and who\n             may benefit from treatment with a PARP inhibitor as assessed by the Investigator.\n\n          -  ECOG performance status of 0 to 2.\n\n          -  Adequate organ function as defined below:\n\n               -  Absolute neutrophil count ? 1,500/?L\n\n               -  Platelets ? 100,000/?L\n\n               -  Hemoglobin ? 9 g/dL (5.6 mM)\n\n               -  Serum creatinine ? 1.5 × the upper limit of normal (ULN) or a calculated\n                  creatinine clearance ? 60 mL/min using the Cockcroft-Gault equation or 24-hour\n                  urine creatinine clearance.\n\n               -  Total bilirubin ? 1.5 × ULN except in patients with Gilbert's syndrome. Patients\n                  with Gilbert's syndrome may enroll if direct bilirubin ? 1.5 × ULN of the direct\n                  bilirubin.\n\n               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 × ULN\n                  unless liver metastases are present, in which case, they must be ? 5 × ULN\n\n          -  Patient has recovered to Grade 1 toxicity from prior cancer therapy (a patient with\n             Grade 2 neuropathy or Grade 2 alopecia is an exception to this criterion and may\n             qualify for this study).\n\n          -  Female Patient of childbearing potential is not breastfeeding, has a negative serum\n             pregnancy test within 72 hours prior to taking study drug and agrees to abstain from\n             activities that could result in pregnancy from Screening through 180 days after the\n             last dose of study drug,\n\n          -  Male patient agrees to use an adequate method of contraception and not donate sperm\n             starting with the first dose of study drug through 90 days after the last dose of\n             study drug\n\n        Key Exclusion, PK Phase:\n\n          -  Known diagnosis of immunodeficiency\n\n          -  Symptomatic uncontrolled brain or leptomeningeal metastases.\n\n          -  Major surgery within 3 weeks of starting the study or patient has not recovered from\n             any effects of any major surgery.\n\n          -  Patient is considered a poor medical risk due to a serious, uncontrolled medical\n             disorder; nonmalignant systemic disease; or active, uncontrolled infection.\n\n          -  Known history of myelodysplastic syndrome or acute myeloid leukemia.\n\n          -  Patient is currently receiving a sensitive cytochrome P450 (CYP) 1A2 substrates with a\n             narrow therapeutic index (e.g., tizanidine and theophylline) (Does not apply for\n             Extension Phase).\n\n          -  Patient is currently taking any of the following P-glycoprotein (P-gp) inhibitors:\n             amiodarone, azithromycin, captopril, carvedilol, clarithromycin, conivaptan,\n             cyclosporine, diltiazem, dronedarone, erythromycin, felodipine, itraconazole,\n             ketoconazole, lopinavir and ritonavir, quercetin, quinidine, ranolazine, ticagrelor,\n             and verapamil (Does not apply for Extension Phase).\n\n          -  Patient taking proton pump inhibitors, antacids, or histamine 2 blockers within 48\n             hours prior to study drug administration, and/or within 6 hours after study drug\n             administration (Does not apply for Extension Phase).\n\n          -  Patient has gastric, gastro-esophageal or esophageal cancer; patient is unable to\n             swallow orally administered medication; or patient has gastrointestinal disorders or\n             significant gastrointestinal resection likely to interfere with the absorption of\n             niraparib.\n\n          -  Patient has known active hepatic disease\n\n          -  Patient has a past or current history of chronic alcohol use.\n\n          -  Patient has significant pleural effusion or ascites that is expected to require\n             drainage during the PK Phase (Does not apply for Extension Phase).\n\n        Key Inclusion, Extension Phase:\n\n          -  ECOG performance status of 0 to 2.\n\n          -  Adequate organ function as defined below\n\n               -  Absolute neutrophil count ? 1,500/?L\n\n               -  Platelets ? 100,000/?L\n\n               -  Hemoglobin ? 9 g/dL (5.6 mM)\n\n               -  Serum creatinine ? 1.5 × the ULN or a calculated creatinine clearance ? 60 mL/min\n                  using the Cockcroft-Gault equation or 24-hour urine creatinine clearance\n\n               -  Total bilirubin ? 1.5 × ULN except in patients with Gilbert's syndrome. Patients\n                  with Gilbert's syndrome may enroll if direct bilirubin ? 1.5 × ULN of the direct\n                  bilirubin.\n\n               -  AST and ALT ? 2.5 × ULN unless liver metastases are present, in which case, they\n                  must be ?5 × ULN\n\n          -  Female patient of childbearing potential is not breastfeeding, has a negative serum\n             pregnancy test within 72 hours prior to taking study drug and agrees to abstain from\n             activities that could result in pregnancy from Screening through 180 days after the\n             last dose of study drug.\n\n          -  Male patient agrees to use an adequate method of contraception and not donate sperm\n             starting with the first dose of study drug through 90 days after the last dose of\n             study drug.Xx_NEWLINE_xXINCLUSION CRITERIA\n\n          1. Patient is ambulatory male or female 16 to 70 years of age at the Screening Visit.\n\n          2. Patient has SCD, including HbSS, HbSC, HbS?0-thalassemia, or HbS?+-thalassemia,\n             documented in their medical history.\n\n          3. If patient is on medication(s) for SCD, such as hydroxyurea (HU), are on a stable\n             regimen.\n\n          4. Per medical history and/or patient recall, patient has had at least 1 and no more than\n             10 sickle cell-related pain crises in the 12 months before the Screening Visit and\n             none occurring in the 4 weeks before the Randomization Visit.\n\n          5. Patient completes daily eDiary entries for at least 10 days during the last 14 days of\n             the Run in Period as assessed at the Randomization Visit.\n\n          6. Women of childbearing potential must have a negative pregnancy test prior to\n             randomization and must agree to use protocol-specified contraception from the\n             Screening Visit through 90 days after the final dose of study drug.\n\n          7. Male patients must be surgically sterile by vasectomy (conducted ?60 days before the\n             Screening Visit or confirmed via sperm analysis) or must agree to use\n             protocol-specified contraception and agree to refrain from sperm donation from the\n             Screening Visit through 90 days after the final dose of study drug.\n\n        EXCLUSION CRITERIA\n\n          1. Patient requires a program of prescheduled, regularly administered chronic blood\n             transfusion therapy.\n\n          2. Patient has been hospitalized for an SCD-related complication in the 4 weeks before\n             the Randomization Visit.\n\n          3. Patient has taken opioid(s) >200 morphine mg equivalent/day within the 4 weeks before\n             the Randomization Visit.\n\n          4. Patient is taking aspirin ?325 mg daily, P2Y12 inhibitors, any anticoagulant\n             medication, specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors\n             of PDE5, moderate or strong cytochrome P450 3A (CYP3A) inhibitors, any supplements for\n             the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide donors\n             in any form.\n\n          5. Patient has major concurrent illness or medical condition that in the opinion of the\n             Investigator would preclude participation in a clinical study.\n\n        NOTE: Other inclusion and exclusion criteria apply, per protocolXx_NEWLINE_xXTreatment with other investigational drugs or anti-cancer therapy within 28 days prior to enrolment.Xx_NEWLINE_xXSystemic antineoplastic therapy or radiotherapy for other malignant conditions within 14 days before the first dose of any study drug, except for hydroxyureaXx_NEWLINE_xXRadiotherapy within 14 days before enrollment (if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib.)Xx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI5083Xx_NEWLINE_xXAny prohibited concomitant medication as per protocol within 28 days of ScreeningXx_NEWLINE_xXUse of an investigational treatment (except for ibrutinib) from 30 days prior to the first doseXx_NEWLINE_xXUsed any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.Xx_NEWLINE_xXMust be willing to implement contraception throughout study and for 120 days after receiving the study drug.Xx_NEWLINE_xXUse of an investigational treatment (except for ibrutinib) from 30 days prior to the first doseXx_NEWLINE_xXHospitalization within 30 days of enrollment for cancer related eventsXx_NEWLINE_xXStatus after bilateral oophorectomy ( 28 days prior to first study treatment) Inclusion Criteria unique to the AR+ve, TNBC cohort:Xx_NEWLINE_xXCytomegalovirus (CMV)- Ongoing infection, treatment, or prophylaxis within the past 28 daysXx_NEWLINE_xXTreatment with an approved or investigational chemotherapy drug within 28 days of Day 1Xx_NEWLINE_xXTreatment with an approved or investigational anti-CD20 drug within 28 days of Day 1Xx_NEWLINE_xXTreatment with an approved or investigational biologic drug that does not target CD20 within 90 days of Day 1Xx_NEWLINE_xXIf patient is receiving steroids, must be on stable or decreasing steroid dose within 5 days prior to treatment initiation with SGT-53.Xx_NEWLINE_xXMale patients must agree not to donate semen or sperm while they are taking carfilzomib and 28 days after the last carfilzomib dose.Xx_NEWLINE_xXTreated with hydroxyurea within 30 days;Xx_NEWLINE_xXIf a female of child-bearing potential, has a negative serum pregnancy test result within 14 days before baseline and agrees to abstain from heterosexual intercourse or use a barrier method for contraception from 14 days before baseline (C1D1) through 30 days after the last study drug dose.Xx_NEWLINE_xXPatients who have experienced significant neuropathy (grades 3-4 or grade 2 with pain) within 14 days prior to registration are NOT eligible for participationXx_NEWLINE_xXPatients who test positive for infectious hepatitis types A, B, or C within 14 days of registration are NOT eligible for participationXx_NEWLINE_xXUnequivocal radiographic evidence of tumor progression by MRI within 14 days prior to registrationXx_NEWLINE_xXLast cytotoxic chemotherapy 28 or more days or biologic therapy treatment 14 or more days before study start (greater than or equal to 42 days if nitrosourea was administered)Xx_NEWLINE_xXHave received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entryXx_NEWLINE_xXMinor surgery within 7 days of first dose of STA-9090Xx_NEWLINE_xXTreatment with systemic cancer therapy within 21 days before screening.Xx_NEWLINE_xXDid not receive any investigational treatment for at least 28 days prior to study entryXx_NEWLINE_xXConcurrent anti-cancer chemotherapy, except TACE (transarterial chemoembolization), during or within 30 days prior to start of study drugXx_NEWLINE_xXConcurrent immunotherapy (including monoclonal antibodies),during or within 30 days prior to start of study drugXx_NEWLINE_xXConcurrent hormonal therapy, except for bisphosphonates,during or within 30 days prior to start of study drugXx_NEWLINE_xXAre instructed to avoid pregnancy through 30 days after the last dose of study medication.Xx_NEWLINE_xXPrior investigational therapy within the past 28 days.Xx_NEWLINE_xXHematocrit >= 30 performed within 60 days of enrollmentXx_NEWLINE_xXSystemic anti-myeloma therapy within <14 days, or plasmapheresis within 7 days prior to the first dose of study drug.Xx_NEWLINE_xX219 Females who are lactating/breastfeeding or who plan to breastfeed while on study through 110 days after receiving the last dose of study drug.Xx_NEWLINE_xX221 Females planning to become pregnant while on study through 110 days after receiving the last dose of study drug.Xx_NEWLINE_xX222 Males who are unwilling to abstain from sperm donation while on study through 170 days after receiving the last dose of study drug.Xx_NEWLINE_xXElectrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.Xx_NEWLINE_xXPatients must be 7 days to 6 weeks out from prior therapy:\r\n* Chemotherapy cytotoxic: At least 21 days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Chemotherapy nitrosoureas: At least 6 weeks since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Chemotherapy non-cytotoxic (e.g. small molecule inhibitor): At least 7 days or five half-lives, whichever is shorter, since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Monoclonal antibody(ies): At least 28 days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Immunotherapy: At least 21 days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Radiotherapy (RT): At least 28 days from last local site RT prior to first dose of tazemetostat\r\n* At least 21 days from stereotactic radiosurgery prior to first dose of tazemetostat\r\n* At least 28 days from craniospinal, > 50% radiation of pelvis or total body irradiation prior to first dose of tazemetostatXx_NEWLINE_xXAppropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination within 28 days prior to registration\r\n* Imaging of the chest, abdomen and pelvis within 30 days prior to registrationXx_NEWLINE_xXA serum thyroid-stimulating hormone (TSH), free T4, and AM (morning) cortisol must be obtained within 14 days prior to randomization to obtain a baseline value and be within normal limits for the local laboratoryXx_NEWLINE_xXSystemic anti-myeloma therapy (including systemic steroids) within 14 days, or plasmapheresis within 7 days prior to the first dose of study drug.Xx_NEWLINE_xXPrior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.Xx_NEWLINE_xXRequired screening laboratory data (within 28 days prior to administration of pembrolizumab)Xx_NEWLINE_xXWillingness and ability to schedule mastectomy 21-28 days following start of study agent; women with breast implants may participateXx_NEWLINE_xXPrior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed.Xx_NEWLINE_xXPatients must not have received valproic acid within 30 days of study entryXx_NEWLINE_xXSubjects must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n* Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea) \r\n* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Cellular therapy: ? 42 days must have elapsed from last dose of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): ? 21 days must have elapsed from the last dose of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Antibodies: ? 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade ? 1\r\n* Palliative radiation therapy (XRT): At least 28 days after local palliative XRT (small port); 6 weeks must have elapsed since treatment with therapeutic doses of 131I-MIBG; at least 42 days must have elapsed if other substantial BM radiation\r\n* Stem cell infusion without traumatic brain injury (TBI): No evidence of active graft versus (vs.) host disease and at least 84 days must have elapsed after transplant and 42 days for autologous stem cell infusion after 131I-metaiodobenzylguanidine (131I-MIBG) therapy\r\n* Prior taxane and nucleoside analogue usage: Patients who have previously received a taxane, including nab-paclitaxel, or a nucleoside analogue, including gemcitabine, are eligible as long as they have not received gemcitabine in combination with nab-paclitaxel\r\n* Medical cannabis and cannabidiol (CBD oil): ? 72 hours must have elapsed since the last administration of these products\r\n* Investigational agents not otherwise specified: ? 30 days must have elapsed since the last dose of any agents not specified above; for agents with an uncertain washout period or for any questions or uncertainty the study principle investigator (PI) should be notifiedXx_NEWLINE_xXRadiotherapy ? 14 days prior to registration; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXReceipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies or other investigational product) =< 28 days; however, if a therapy has a short half-life, then patients may participate if they received prior treatment =< 28 days from starting study treatment with approval from the principal investigator (PI) and AstraZeneca/Janssen; acceptable washout periods include:\r\n* 3-14 days for prior tyrosine kinase inhibitor (TKI) depending on half-life\r\n* 14-28 days for prior PD-1 or PD-L1 inhibitor treatment depending on the frequency of administration (i.e., wait one full cycle of prior PD-1 axis inhibition before starting study drugs)Xx_NEWLINE_xXExclusion criteria related to study medication:\r\n* Current or recent (within 10 days of study enrollment) use of acetylsalicylic acid (> 325 mg/day), clopidogrel (> 75 mg/day) or current or recent (within 10 days of first dose of bevacizumab) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose. Note: The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or partial thromboplastin time (aPTT) is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks at the time of cycle 1 day 1. Prophylactic use of anticoagulants is allowed\r\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins\r\n* Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells, any components of binimetinib, pembrolizumab, or bevacizumab formulations or any premedications\r\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, anti-PD L1, anti-PD-L2 or MAPK pathway inhibitors (eg; BRAF, MEK, ERK inhibitors)\r\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomizationXx_NEWLINE_xXPatient is anticipated to continue for at least 28 days with an EGFR inhibitor or restart ? 14 days of registration and continue for at least 28 daysXx_NEWLINE_xXMagnesium >= LLN =< 14 days prior to registration\r\n* NOTE: Supplementation may be given before the first dose of study medicationXx_NEWLINE_xXSodium >= LLN =< 14 days prior to registration\r\n* NOTE: Supplementation may be given before the first dose of study medicationXx_NEWLINE_xXPhosphorus >= LLN =< 14 days prior to registration\r\n* NOTE: Supplementation may be given before the first dose of study medicationXx_NEWLINE_xXBrain metastases considered unstable as: a. without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR b. associated with symptoms and/or findings; OR c. requiring corticosteroids or anticonvulsants in the prior 60 days.Xx_NEWLINE_xXTreatment with any investigational drug within 28 days prior to initiating study medicationsXx_NEWLINE_xXThe patient has a caregiver for 28 days after dosing with C. novyi-NTXx_NEWLINE_xXHas received monoamine oxidase inhibitors within 21 days prior to starting studyXx_NEWLINE_xXPatients participating in an investigational new drug protocol within 14 days before enrollment.Xx_NEWLINE_xXWithin 14 days of study registration: No oxygen requirement on room air or requiring =< 2L supplemental oxygen (O2)Xx_NEWLINE_xXMonoclonal antibody within 28 days prior to day 1 of protocol therapyXx_NEWLINE_xXAble to be off prednisone or other immunosuppressive medications for at least 3 days prior to transplant (excluding preparative regimen premedications)Xx_NEWLINE_xXReceived any investigational drugs within the 14 days before 1st dose of fludarabineXx_NEWLINE_xXActive infection =< 5 days prior to registration or fever > 38 degrees Celsius (C) on day of registrationXx_NEWLINE_xXClarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligibleXx_NEWLINE_xXObtained within 28 days prior to registration: Bilirubin =< 1.5 mg/dLXx_NEWLINE_xXObtained within 28 days prior to registration: Platelets > 100,000 cells/mm^3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)Xx_NEWLINE_xXTreatment with any investigational products within 28 days prior to study registrationXx_NEWLINE_xXReceived any systemic treatment for pancreatic cancer =< 14 days prior to first dose of rucaparibXx_NEWLINE_xXPatients must have a complete history and physical examination within 30 days prior to registrationXx_NEWLINE_xXAICD firing within the last 30 daysXx_NEWLINE_xXPatients with stable seizures (e.g., no seizures for >= 14 days and not requiring escalation or addition of anti-epileptic drugs) will be eligibleXx_NEWLINE_xXAny number of biologic therapies (e.g., bevacizumab) or immunotherapies is allowed in the absence of co-administered chemotherapy and must have been completed >= 28 days prior to randomizationXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have had prior exposure to tazemetostat or other inhibitor(s) of EZH2Xx_NEWLINE_xXPatients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroidXx_NEWLINE_xXNo treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registrationXx_NEWLINE_xXAny number of the following prior therapies is allowed:\r\n* Chemotherapy >= 28 days prior to registration\r\n* Mitomycin C/nitrosoureas >= 42 days prior to registration\r\n* Immunotherapy >= 28 days prior to registration\r\n* Biologic therapy >= 28 days prior to registration\r\n* Targeted therapy >= 28 days prior to registration\r\n* Radiation therapy >= 28 days prior to registration\r\n* Radiation to < 25% of bone marrowXx_NEWLINE_xXMale subjects who are not employing an effective method of birth control from starting dose of durvalumab (cycle 1 day 1), including dosing interruptions through 90 days after receipt of the last dose of durvalumab; refrain from sperm donation while taking durvalumab and for at least 90 days after the last dose of durvalumabXx_NEWLINE_xXNo uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease) within 28 days of registrationXx_NEWLINE_xXTo be performed within 28 days prior to day 1 of protocol therapy: Normal eye examinationXx_NEWLINE_xXIf the subject has enzalutamide discontinuation for >7 days prior to dosing start with GSK525762 plus enzalutamide on trial, then a enzalutamide only lead-in dosing of 28 days is requiredXx_NEWLINE_xXIf the subject has enzalutamide discontinuation for <=7 days prior to dosing start with GSK525762 plus enzalutamide on trial, then a enzalutamide only lead-in dosing of 14 days is requiredXx_NEWLINE_xXRecent prior therapy, defined as: Any investigational or approved non-biologic anti-cancer drug (see exception below) within 14 days prior to the first dose of GSK525762 and abiraterone/enzalutamide. Exception: For allowed androgen deprivation therapy (hormonal, abiraterone, enzalutamide. Concomitant prednisone (or equivalent) allowed in combination with abiraterone dosing, any nitrosoureas or mitomycin C within 42 days prior to the first dose of GSK525762 and abiraterone/enzalutamide, any anti-cancer biologic agents within five half-lives prior to the first dose of GSK525762 and abiraterone/enzalutamide, if the subject received radiotherapy <90 days prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response. Exception: Any radiotherapy within 14 days prior to the first dose of GSK525762 and abiraterone/enzalutamide must be limited to a single fraction of radiotherapy for the purpose of palliation (confined to one field) is permitted, any major surgery within 28 days prior to the first dose of GSK525762 and abiraterone/enzalutamideXx_NEWLINE_xXConsumption of agents which strongly inhibit CYP3A4 enzyme, within 7 days prior to the first dose of study treatment and during the study.Xx_NEWLINE_xXConsumption of agents which strongly induce CYP3A4 enzyme, within 14 days prior to the first dose of study treatment and during the study.Xx_NEWLINE_xXPatient has any of the following within 14 days prior to the first dose of study drug:Xx_NEWLINE_xXTreatment with systemic corticosteroid or immune-modulators =< 30 days prior to randomizationXx_NEWLINE_xXWithin 14 days prior to registration: Magnesium within institution’s normal rangeXx_NEWLINE_xXWithin 14 days prior to registration: Serum bilirubin =< 1.5 x institution’s ULNXx_NEWLINE_xXThe patient must have failed at least one prior therapy - surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapy - prior to study registration; patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Myelosuppressive chemotherapy: Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks prior if nitrosourea\r\n* Biologic agent: Patient must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent >= 7 days prior to study registration\r\n** For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended to beyond the time during which adverse events are known to occur; the duration of this interval should be discussed with the study chair\r\n** For biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registration\r\n* Monoclonal antibody treatment: At least three half-lives must have elapsed prior to registration; such patients should be discussed with the study chair prior to registration\r\n* For bevacizumab, patients must have received last dose >= 32 days prior to study registration\r\n* Bone marrow transplant: Patient must be:\r\n** >= 6 months since allogeneic bone marrow transplant prior to registration\r\n** >= 3 months since autologous bone marrow/stem cell prior to registrationXx_NEWLINE_xXAnti-measles virus immunity as demonstrated by IgG anti-measles antibody per institutional guidelines (within 21 days prior to study registration)Xx_NEWLINE_xXPatients with current use of megestrol acetate (use within 10 days of day 1) will be excludedXx_NEWLINE_xXSubject is receiving or is less than 14 days since ending other experimental drug (no marketing authorization for any indication)Xx_NEWLINE_xXWithin 28 days of study registration: Platelets >= 100,000 cells/mm^3 (independent of blood transfusion and/or growth factors within 3 months prior to registration)Xx_NEWLINE_xXWithin 28 days of study registration: Potassium >= 3.5 mmol/LXx_NEWLINE_xXHistory/physical examination within 28 days prior to registrationXx_NEWLINE_xXExamination by Radiation Oncologist, Medical Oncologist, and Ear, Nose, Throat (ENT) or Head & Neck Surgeon within 28 days prior to registrationXx_NEWLINE_xXFiberoptic exam with laryngopharyngoscopy within 28 days prior to registrationXx_NEWLINE_xXAll laboratory assessments should be performed within 21 days of initiation of protocol therapy unless otherwise specifiedXx_NEWLINE_xXReceived the following within 7 days prior to the initiation of study treatment:Xx_NEWLINE_xXAny approved AML-related therapy within 14 days prior to enrollmentXx_NEWLINE_xXPatients must be > 28 days from the start of induction or re-induction chemotherapy, or from the start of consolidation cycle 1 (if received) and < 90 days following recovery from most recent treatment; and they must have achieved and maintained a response to induction therapy (CR, CRi, or “morphologic disease-free state”)Xx_NEWLINE_xXThe subject has received radiation therapy:\r\n* To bone metastasis within 14 days before the first dose of study treatment \r\n* To any other site(s) within 28 days before the first dose of study treatmentXx_NEWLINE_xXPatients must have adequate organ and bone marrow function =< 14 days prior to registration, as defined below (Note: blood transfusion or growth factors is not permitted within 14 days of registration):Xx_NEWLINE_xXPatients are not eligible who have received systemic chemotherapy or investigational agents =< 28 days prior to registrationXx_NEWLINE_xXPatients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration for >= 14 days\r\n* NOTE: Vitamin supplements are acceptableXx_NEWLINE_xXPatient must not have received pegfilgrastim within 14 days of enrollmentXx_NEWLINE_xXPatient must not have received filgrastim (G-CSF, Neupogen) within 7 days of enrollmentXx_NEWLINE_xXSubjects under the age of 18 must have had prior therapy according to the best available therapy as determined by their primary brain tumor specialist (to include oncology, neurosurgery and/or radiation oncology) including systemic and/or cranial or spinal radiation or chemotherapy; subjects over the age of 18 may be enrolled as part of first-line treatment; those subjects who enroll as first-line treatment will not be restricted from traditional treatments in the future; at least 14 days must have elapsed since completion of cranial radiotherapy and 28 days since completion of chemotherapy; at least 28 days must have elapsed since completion of total spine radiotherapyXx_NEWLINE_xXPatients must have a contraindication to cisplatin as defined in the following bullet points; sites must complete the online tool at comogram.org prior to step 1 registration to determine if the patient is eligible; the scores must be recorded on a case report form (CRF)\r\n* Age >= 70 with moderate to severe comorbidity or vulnerability to cisplatin, defined as having any one of the following conditions within 30 days prior to step 1 registration:\r\n** Modified Charlson Comorbidity Index >= 1\r\n** Adult Comorbidity Evaluation (ACE)-27 Index >= 1\r\n** Generalized Competing Event Model for Cancer Risk (GCE) omega PFS score < 0.60 \r\n** Geriatric screening (G-8) score =< 14\r\n** Cancer and Aging Research Group (CARG) toxicity score >= 30%\r\n** Cumulative Illness Rating scale for Geriatrics (CIRS-G) score >= 4 OR\r\n* Age < 70 with severe comorbidity or vulnerability to cisplatin, defined as having two or more of the following conditions within 30 days prior to step 1 registration \r\n** Modified Charlson Comorbidity Index >= 1\r\n** ACE-27 Index >= 1\r\n** GCE omega PFS-score < 0.60 \r\n** G-8 score =< 14\r\n** CARG Toxicity score >= 30%\r\n** CIRS-G score >= 4 OR\r\n* Age >= 18 with an absolute or relative contraindication to cisplatin, defined as one or more of the following within 30 days prior to Step 1 registration:\r\n** Creatinine clearance (CC) > 30 and < 60 cc/min; for this calculation, use the Cockroft-Gault formula\r\n** Zubrod performance status 2 prior to step 1 registration\r\n** Pre-existing peripheral neuropathy grade >= 1\r\n** History of hearing loss, defined as either: \r\n*** Existing need of a hearing aid OR \r\n*** >= 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing testXx_NEWLINE_xXWithin 14 days of step 1 registration, unless corrected prior to step 1 registration: Sodium < 130 mmol/L or > 155 mmol/LXx_NEWLINE_xXWithin 14 days of step 1 registration, unless corrected prior to step 1 registration: Potassium < 3.5 mmol/L or > 6 mmol/LXx_NEWLINE_xXWithin 14 days of step 1 registration, unless corrected prior to step 1 registration: Magnesium < 0.9 mg/dl or > 3 mg/dlXx_NEWLINE_xXPatients must have fully recovered from the acute non-hematologic toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to =< grade 2 or lower per the inclusion/exclusion criteria prior to entering this study\r\n* Myelosuppressive chemotherapy:\r\n** No waiting period will be required for patients receiving standard \maintenance-like\ chemotherapy including oral mercaptopurine, weekly low-dose oral methotrexate, and intermittent vincristine; otherwise, at least 14 days must have elapsed since the completion of cytotoxic therapy, with the exceptions of hydroxyurea or corticosteroids used for cytoreduction\r\n** Intrathecal cytotoxic therapy: No waiting period is required for patients having received intrathecal cytarabine, methotrexate, and/or hydrocortisone; intrathecal chemotherapy given at the time of diagnostic lumbar puncture (LP) to evaluate for relapse prior to study enrollment is allowed\r\n* At least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim\r\n* At least 7 days must have elapsed since completion of therapy with a biologic agent (including tyrosine kinase inhibitors); for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur\r\n* At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody with the exception of blinatumomab; patients must have been off blinatumomab infusion for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria \r\n* >= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); >= 3 months must have elapsed if prior cranial or craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total-body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given\r\n* At least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion; patient must have had no more than one previous HSCT and currently have no evidence of active graft versus (vs.) host disease (GVHD)\r\n* At least 30 days must have elapsed from the last chimeric antigen receptor (CAR)-T cell infusionXx_NEWLINE_xXSubject has received small molecule therapy, radiotherapy, immunotherapy, monoclonal antibodies, investigational drug, or chemotherapy within 14 days before first dose of study drug, with the exception of hydroxyureaXx_NEWLINE_xXPatients must have fully recovered (to grade 1) from the acute toxic effects of all prior anti-cancer therapy\r\n* Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody\r\n* External beam radiation therapy (XRT): at least 7 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI) or if >= 50% radiation of pelvis; >= 14 days from whole brain radiation, craniospinal radiation, or targeted radiation to central nervous system (CNS) tumors; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Hematopoietic stem cell transplantation (HSCT): >= 56 days from stem cell transplant with no evidence of active graft versus (vs) host disease; must be off immunosuppressive therapy for at least 4 weeks and have no active graft-versus-host disease (GVHD) at the time of entry onto this trial\r\n* Surgery: >= 14 days from surgery\r\n* Others: >= 7 days from last dose of short active hematopoietic growth factors, i.e. filgrastim, >= 14 days for long-acting, i.e. pegfilgrastim\r\n* Steroids: patients with CNS tumors who are managed with steroids are eligible if they have no worsening neurologic deficits and are on a stable or decreasing dose of corticosteroids for greater than or equal to 7 days prior to registration; patients with leukemia receiving corticosteroids or hydroxyurea are eligible provided that the corticosteroids are not being used to manage GVHD and there has been no increase in corticosteroid of hydroxyurea dose for 7 days prior to starting PLX3397Xx_NEWLINE_xXUse of any investigational agent within the last 28 days. For classes of investigational agents that are not known to have prolonged toxicities the wash-out time may be decreased to 14 days after agreement with the Medical Monitor.Xx_NEWLINE_xXPatients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-L-Ly or for any cancer diagnosis prior to the initiation of protocol therapy on AALL1231, with the exception of:\r\n* Steroid pretreatment: prednisone or methylprednisolone for =< 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for =< 336 hours (14 days) in the 28 days prior to initiating induction chemotherapy; prior exposure to ANY steroids that occurred > 28 days before the initiation of protocol therapy does not affect eligibility; the dose of prednisone or methylprednisolone does not affect eligibility\r\n* Intrathecal cytarabine (the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) system chemotherapy must begin with 72 hours of this IT therapy; or\r\n* 600 cGy of chest irradiation, if medically necessary\r\n** Pre-treatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone use during sedation to prevent or treat airway edema; inhalation steroids and topical steroids are not considered pretreatmentXx_NEWLINE_xXTREATMENT: Breastfeeding should be discontinued while the patient is on this trial and for 30 days following last dose of study drugXx_NEWLINE_xXARM A: obtained =< 14 days prior to registration: \r\n* Creatinine =< 1.5 x ULNXx_NEWLINE_xXARM A: Any corticosteroid use =< 28 days prior to registrationXx_NEWLINE_xXARM A: Any radioembolization or transarterial chemoembolization (TACE) =< 84 days prior to registrationXx_NEWLINE_xXARM B: obtained =< 14 days prior to registration: \r\n* Creatinine =< 1.5 x ULNXx_NEWLINE_xXARM B: obtained =< 14 days prior to registration: \r\n* INR =< 1.5 x ULNXx_NEWLINE_xXARM B: obtained =< 14 days prior to registration: \r\n* aPTT =< 1.5 x ULNXx_NEWLINE_xXARM B: Any corticosteroid use =< 28 days prior to registrationXx_NEWLINE_xXARM B: Any radioembolization or TACE =< 84 days prior to registrationXx_NEWLINE_xXPatients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123; patients must be enrolled within 31 days of definitive diagnostic surgery (day 0) or clinical diagnosisXx_NEWLINE_xXREGISTRATION:Xx_NEWLINE_xXWomen may have been taking tamoxifen or raloxifene as a preventive agent prior to study entry but must have discontinued the drug for at least 21 days prior to study enrollmentXx_NEWLINE_xXAll patients must have completed any prior chemotherapy, targeted therapy and major surgery, >= 28 days before study entry; for daily or weekly chemotherapy without the potential for delayed toxicity, a washout period of 14 days may be acceptable, and questions related to this can be discussed with study principal investigatorXx_NEWLINE_xXPatients enrolled to the prior treatment arm of the dose escalation cohort must not have received anti-cancer therapy less than 14 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drugXx_NEWLINE_xXObtained within 14 days (or as stipulated) prior to study drug (treatment) administration: total bilirubin ? 2.0 mg/dL or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinemiaXx_NEWLINE_xXPrior therapy with TEW-7197 or received any investigational drug within the prior 28 daysXx_NEWLINE_xXAppropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination within 28 days prior to registration\r\n* Imaging of target lesion(s) within 28 days prior to registration\r\n* Completion of pre-study protocol specific assessments as requiredXx_NEWLINE_xXDaily oral or intravenous corticosteroids for 7 days or longer within one week of enrollment and patient is anticipated to have an increase in dose after study enrollmentXx_NEWLINE_xXBiologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent such as steroids, retinoids; Note: for agents that have known adverse events occurring beyond 7 days after administration (i.e. monoclonal antibodies), this period must be extended beyond the time during which acute adverse events are known to occurXx_NEWLINE_xXPrior treatment with any other agent that may affect M-protein =< 30 days prior to registrationXx_NEWLINE_xXInvestigational drug use within 28 days of the first dose of PLX3397 or concurrentlyXx_NEWLINE_xXScan within 14 days prior to initiation of study vaccinations shows no evidence of progressive disease prior to study vaccination initiation based on the Response Assessment in Neuro-Oncology (RANO) criteria; participant with progressive disease after radiation therapy will not be a candidate for the vaccine despite being previously enrolled and will be removed from the study and replacedXx_NEWLINE_xX-  Patients must have a histologically confirmed diagnosis of invasive breast carcinoma\n             with positive estrogen and/or progesterone receptor status, and negative human\n             epidermal growth factor receptor (HER-2), for whom endocrine therapy is planned.\n\n          -  The HER-2 test result is negative (and should be reported as such), if a single test\n             (or all tests)performed in a tumor specimen show:\n\n               -  Immunohistochemistries (IHC) 1+ negative or IHC 0 negative or\n\n               -  in situ hybridization (ISH) negative using a single probe ISH or dual probe ISH.\n\n          -  Estrogen receptor (ER) and progesterone receptor (PgR) positivity must be assessed\n             according to American Society of Clinial Oncology (ASCO)/College of American\n             Physicians (CAP) guidelines as either ER or PR ? 1% positive nuclear staining. If HER2\n             IHC is 2+, an evaluation for gene amplification must be performed and the gene must\n             not be amplified. Gene amplification evaluation is not required if evaluation by IHC\n             is 0 or 1+ by institutional standards.\n\n          -  Patients must be post-menopausal women with a confirmed diagnosis of metastatic breast\n             cancer (M1). Pathologic confirmation of histology is preferable. In the case of bone\n             metastases only, biopsy-proven metastatic disease of solitary site, or multiple sites\n             of involvement are required. Post-menopausal is defined by one of the following\n             criteria as per National Comprehensive Cancer Network (NCCN) guidelines Version 3.\n             2013:\n\n               -  Prior bilateral oophorectomy and/or hysterectomy\n\n               -  Patients ? 60 years of age\n\n               -  Patients < 60 years of age and amenorrheic for ? 12 months in the absence of\n                  chemotherapy, tamoxifen, toremifene, or ovarian suppression and\n                  follicle-stimulating hormone (FSH) and estradiol in the post-menopausal range\n\n               -  Patients < 60 years of age taking tamoxifen or toremifene must have FSH and\n                  plasma estradiol levels within post-menopausal ranges\n\n          -  Patients must have measurable or evaluable disease. Patients must have a chest and\n             abdominal computerized tomography (CT) and bone scan within 28 days prior to\n             registration. All scans needed for assessment of measurable disease must be performed\n             within 28 days prior to registration. Evaluable disease must be assessed within 28\n             days prior to registration\n\n          -  Patients with a history of prior chemotherapy or hormone therapy or immunotherapy for\n             recurrent or metastatic disease are NOT eligible. Prior adjuvant or neoadjuvant\n             chemotherapy if completed more than 12 months prior to registration is acceptable. Any\n             number of prior hormonal therapy regimens for the adjuvant setting but not for\n             metastatic or recurrent disease is allowed; prior adjuvant or neoadjuvant treatment\n             with an aromatase inhibitor (e.g. anastrozole, letrozole, exemestane) is allowed, if\n             completed more than 12 months prior to randomization.\n\n          -  Patients who have taken luteinizing hormone-releasing hormone (LHRH) analogue as\n             adjuvant therapy are eligible provided they have a) discontinued such therapy at least\n             12 months prior to registration AND b) have not resumed their menstrual periods.\n\n          -  Patients must not have had prior exposure to fulvestrant or mTOR inhibitors (e.g.,\n             rapamycin, everolimus, temsirolimus, deforolimus). Concurrent bisphosphonate therapy\n             is allowed. Patients must not have prior treatment with any investigational drug\n             within 28 days prior to registration and must not be planning to receive any other\n             investigational drug for the duration of the study.\n\n          -  Patients must have an International Normalized Ratio (INR) ? 1.6 within 28 days prior\n             to registration.\n\n          -  Patients must have adequate bone marrow function, as defined by Absolute Neutrophil\n             Count (ANC) of ? 1,500/mL, hemoglobin ? 9 g/dL and a peripheral platelet count ?\n             100,000/ mL, all within 28 days prior to registration.\n\n          -  Patients must have adequate hepatic function obtained within 28 days prior to\n             registration and documented by all of the following:\n\n               -  Bilirubin ? 1.5 mg/dL (or ? 3.0 mg/dL if due to Gilbert's Syndrome)\n\n               -  alanine aminotransferase (ALT) (SGPT) and aspartate aminotransferase (AST) (SGOT)\n                  ? 2.5 x Institutional Upper Limit of Normal (IULN), or ? 5 x IULN if hepatic\n                  metastases are present.\n\n          -  Patients must have adequate renal function with serum creatinine level ? IULN within\n             28 days prior to registration.\n\n          -  Patients must have a fasting cholesterol ? 300 mg/dL and triglycerides ? 2.5 x IULN\n             obtained within 28 days prior to registration. Patients may be on lipid lowering\n             agents to reach these values.\n\n          -  Patients must have a complete history and physical examination within 28 days prior to\n             registration.\n\n          -  Patients with bleeding diathesis (i.e., disseminated intravascular coagulation [DIC],\n             clotting factor deficiency) or long-term anti-coagulant therapy (other than\n             antiplatelet therapy) are NOT eligible.\n\n          -  Patients with presence of life-threatening metastatic visceral disease, defined as\n             extensive hepatic involvement, or any degree of brain or leptomeningeal involvement\n             (past or present), or symptomatic pulmonary lymphangitic spread are not eligible.\n             Patients with discrete pulmonary parenchymal metastases are eligible, provided their\n             respiratory function is not significantly compromised as a result of disease in the\n             opinion of the investigator.\n\n          -  Patients must have a performance status of 0 - 2 by Zubrod criteria.\n\n          -  Patients must not have any Grade III/IV cardiac disease as defined by the New York\n             Heart Association Criteria (i.e., patients with cardiac disease resulting in marked\n             limitation of physical activity or resulting in inability to carry on any physical\n             activity without discomfort), unstable angina pectoris, myocardial infarction within 6\n             months, or serious uncontrolled cardiac arrhythmia.\n\n          -  Patients must not have uncontrolled diabetes (defined as an Hg A1C >7% within 28 days\n             prior to registration).\n\n          -  Patients must not have an organ allograft or other history of immune compromise.\n             Patients must not be receiving chronic, systemic treatment with corticosteroids or\n             other immunosuppressive agent. Topical or inhaled corticosteroids are allowed.\n\n          -  Patients known to be HIV positive may be enrolled if baseline CD4 count is > 500\n             cells/mm3 AND not taking anti-retroviral therapy. Patients with known chronic or\n             active hepatitis are not eligible. Patients must not have any known uncontrolled\n             underlying pulmonary disease.\n\n          -  Patients must be able to take oral medications. Patient may not have any impairment of\n             gastrointestinal function or gastrointestinal disease that may significantly alter the\n             absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting,\n             diarrhea, malabsorption syndrome or small bowel resection).\n\n          -  Patients must not have received immunization with an attenuated live vaccine (e.g.\n             intranasal influenza, MMR, oral polio, varicella, zoster, yellow fever and BCG\n             vaccines) within seven days prior to registration nor have plans to receive such\n             vaccination while on protocol treatment.\n\n          -  Patients must not have taken within 14 days prior to registration, be taking, nor plan\n             to take while on protocol treatment, strong CYP3A4 inhibitors, and/or CYP3A4 inducers.\n\n          -  No other prior malignancy is allowed except for adequately treated basal cell or\n             squamous cell skin cancer, in situ cervical cancer or other cancer for which the\n             patient has been disease-free for 5 years.Xx_NEWLINE_xXWhile there will be no restrictions on concurrent systemic medications, all subjects must be on a stable immunomodulatory medication regimen for 7 days prior to beginning the study without plans to adjust doses during the following four-week study period; dose modifications to maintain therapeutic drug levels of immunosuppressants (i.e. tacrolimus and sirolimus) during the study intervention period are allowed and do not constitute a trial violation; changes in medications for non-cGVHD medical conditions will not affect eligibilityXx_NEWLINE_xXStable topical steroid therapy with dexamethasone, clobetasol, or budesonide oral solutions (5 min, four times a day) for seven days prior to study enrollmentXx_NEWLINE_xXStable systemic cGVHD medication regimen for seven days prior to study enrollment; dose modifications to maintain therapeutic drug levels of immunosuppressants (i.e. tacrolimus and sirolimus) for the month prior and during the study intervention period are allowed and do not constitute a trial violationXx_NEWLINE_xXAt least 14 days must lapse between last prior anti-cancer treatment and 1st day of preparative regimenXx_NEWLINE_xXBaseline MRI within 17 days of Day 1 & on steroid dosage that has been stable or decreasing for at least 5 daysXx_NEWLINE_xXPSA is mandatory (< 60 days prior to registration)Xx_NEWLINE_xXNo prior therapy is allowed except for the following:\r\n* Corticosteroids: short courses of corticosteroid (defined as =< 7 days of corticosteroids within the 4 weeks preceding registration) are allowed prior to registration; note: if patient has received pre-treatment with corticosteroids, they should not receive steroid prophase\r\n** Participants who have been on corticosteroids chronically (defined as more than 7 days of corticosteroids within the 4 weeks preceding registration or more than 28 days of corticosteroids over the preceding 6 months) are not eligible\r\n* IT cytarabine: a single dose of intrathecal cytarabine (at the time of the diagnostic lumbar puncture) is allowed prior to registration; if patient has received IT cytarabine prior to registration, day 1 IT cytarabine should not be administered\r\n* Emergent radiation therapy: emergent radiation to the mediastinum or other life-threatening masses is allowed prior to registrationXx_NEWLINE_xXParticipants who have received more than 7 days of corticosteroids in the preceding 4 weeks or more than 28 days of corticosteroids in the preceding 6 months are not eligibleXx_NEWLINE_xXThe subject has received radiation therapy:\r\n* To the thoracic cavity or gastrointestinal tract within 3 months of the first dose of study treatment\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatmentXx_NEWLINE_xXWithin 30 days of registration: Oxygen saturation >= 90% on room airXx_NEWLINE_xXConcurrent systemic immunosuppressant therapy other than corticosteroids (e.g., cyclosporine A, tacrolimus, etc.) within 28 days of the first dose of study drugXx_NEWLINE_xXHemoglobin A1c (HbA1c) < 7% obtained within 28 days prior to sub-study registrationXx_NEWLINE_xXHbA1c < 7% obtained within 28 days prior to Step 2 re-registrationXx_NEWLINE_xXPrestudy history and physical exam must be obtained within 28 days prior to re-registrationXx_NEWLINE_xXNon-study related surgical procedures less than or equal to 7 days prior to\n             administration of rociletinib. In all cases, the patient must be sufficiently\n             recovered and stable before treatment administrationXx_NEWLINE_xXPatients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease prostate specific antigen (PSA) levels (e.g. saw palmetto, PC-SPES), or any systemic corticosteroid, must discontinue the agent for at least 30 days prior to study treatmentXx_NEWLINE_xXPatients who have received prior immunosuppressive therapy within 30 days prior to enrollmentXx_NEWLINE_xXPatients who have received hepatotoxic drugs less than 7 days prior to enrollmentXx_NEWLINE_xXPatients who have received prior biologic agents less than 30 days prior to enrollmentXx_NEWLINE_xXRadiotherapy =< 14 days prior to registration\r\n* NOTE: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of study drugsXx_NEWLINE_xXPatients who have been off of FOLFIRINOX more than 70 days prior to treatment on studyXx_NEWLINE_xXPatients must not have received nitrosourea or mitomycin C within 42 days prior to sub-study registrationXx_NEWLINE_xXPatients must have an eye exam performed within 28 days prior to sub-study registration; patients with uncontrolled glaucoma or intra-ocular pressure >= 21 mm Hg at screening should be referred for ophthalmological management and the condition controlled prior to registrationXx_NEWLINE_xXPatients must have albumin, urinalysis, and Troponin I obtained within 7 days prior to sub-study registrationXx_NEWLINE_xXPatients must have albumin, urinalysis, and Troponin I obtained within 7 days prior to substudy registrationXx_NEWLINE_xXPatients must have corrected calcium and phosphate < ULN obtained within 7 days prior to sub-study registrationXx_NEWLINE_xXPatients must have MUGA/echocardiogram performed within 28 days prior to sub-study registrationXx_NEWLINE_xXPrestudy history and physical exam must be obtained within 28 days prior to re-registrationXx_NEWLINE_xXPatients must not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment drugs that are known to prolong the QT intervalXx_NEWLINE_xXPatients must have a Na, K, Cl, Ca, Mg, and HbA1c performed within 7 days prior to sub-study registrationXx_NEWLINE_xXPre-study history and physical exam must be obtained within 28 days prior to re-registrationXx_NEWLINE_xXParticipation in a prior investigational study within 30 days prior to enrollmentXx_NEWLINE_xXBiologic (anti-neoplastic) agent: at least 7 days since the completion of therapy with a biologic agent or donor lymphocyte infusions (DLI); for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occurXx_NEWLINE_xXReceived investigational drugs within the 14 days of study registrationXx_NEWLINE_xXWithin 14 days of subject registration: Serum creatinine =< 1.5 X IULNXx_NEWLINE_xXDocumentation of steroid doses 10-14 days prior to study registration and stable or decreasing steroid dose over the week prior to registrationXx_NEWLINE_xXAppropriate for study entry based on the following diagnostic workup:\r\n* History/physical examination within 28 days prior to registration\r\n* Imaging of target lesion(s) within 28 days prior to registration\r\n* Further protocol-specific assessments:\r\n** Recovery from adverse effects of recent surgery, radiotherapy or chemotherapy\r\n** Any other prior therapy directed at the malignant tumor including chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at least three weeks prior to registration\r\n** Investigation agents must be discontinued for at least 30 days prior to registration\r\n** Any prior radiation therapy must be completed at least 4 weeks prior to registration\r\n** At least 4 weeks must have elapsed since any major surgery prior to registrationXx_NEWLINE_xXNormal thyroid function testing (thyroid stimulating hormone [TSH]) within 14 days prior to registrationXx_NEWLINE_xXSystemic chemotherapy washout period >= 7 days; for investigational dugs and monoclonal antibodies washout period >= 5 x drug half-life; there are no limitations on number of prior treatment regimensXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n* Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Biologic (anti-neoplastic agent): at least 14 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody\r\n* Radiation therapy (XRT): at least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal and/or entire spinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Stem cell infusion without TBI: no evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusionXx_NEWLINE_xXBiologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chairXx_NEWLINE_xXPatients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 28 days prior to study enrollment; patients who enter the study on thyroid replacement should have their medication adjusted to maintain thyroid-stimulating hormone (TSH) in the normal rangeXx_NEWLINE_xXPatient who has received investigation agent within 30 days prior to enrollmentXx_NEWLINE_xXSerum direct bilirubin (DB) =< 1.5 times ULN within 14 days prior to admissionXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n* Myelosuppressive chemotherapy:\r\n** Solid tumors (Part A and Part B): at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** Acute lymphoblastic leukemias (ALL) (Part C):\r\n*** Patients with leukemia who relapse while receiving standard maintenance chemotherapy will not be required to have a waiting period before enrollment onto this study\r\n*** Patients who relapse while they are not receiving standard maintenance therapy, must have fully recovered from all acute toxic effects of prior therapy; at least 14 days must have elapsed after the completion of cytotoxic therapy, with the exception of hydroxyurea\r\n*** Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of BMN 673\r\n*** Note: patients with leukemia are permitted to receive intrathecal chemotherapy, including methotrexate or cytarabine; intrathecal therapy should be restricted to days 15 and 22 of each 28 day cycle \r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody\r\n* Radiation therapy (XRT): at least 14 days after local palliative XRT (small port); at least 42 days must have elapsed if other substantial bone marrow (BM) radiation; patients with prior total body irradiation (TBI), craniospinal XRT and/or >= 50% radiation of the pelvis are not eligible\r\n* Stem cell infusion without TBI: no evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusionXx_NEWLINE_xXNeurologic symptoms or imaging findings that necessitate the use of steroids on the day of enrollment or in the prior 7 daysXx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708Xx_NEWLINE_xXAt least 7 days must have passed since the last treatment with lenalidomide, pomalidomide, thalidomide, proteasome inhibitors, or low dose cyclophosphamide (up to 50 mg daily), at least 21 days must have passed since the last treatment with daratumumab, elotuzumab, investigational therapy and most conventional chemotherapy including cyclophosphamide, bendamustine, doxorubicin, cisplatin, and etoposide; and at least 35 days since the last treatment with melphalanXx_NEWLINE_xXPatients must be enrolled on study within 31 days of definitive surgical resection at which time tissue is acquired to determine a diagnosis; patients must be enrolled before treatment begins; the date protocol therapy is projected to start must be no later than five (5) calendar days after the date of study enrollment; patients who are started on protocol therapy on a Phase II study prior to study enrollment will be considered ineligibleXx_NEWLINE_xXAny major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 14 days prior to enrollment and/or daily or weekly chemotherapy with the potential for delayed toxicity within 14 days prior to enrollmentXx_NEWLINE_xXUse of any investigational product within 30 days prior to randomizationXx_NEWLINE_xXPrior recent systemic or investigational therapy within 21 days of initiation of study treatment; an exception is that EGFR inhibitor may be continued up until 3 days of initiation of study treatmentXx_NEWLINE_xXUse of other investigational drugs within 28 days preceding the first dose of trametinib and during the studyXx_NEWLINE_xXAny other prior therapy directed at the malignant tumor, including chemotherapy and immunotherapy, must be discontinued at least three weeks prior to registration; any investigational agent must be discontinued at least 30 days prior to registrationXx_NEWLINE_xXPatients must have measurable disease within 28 days prior to registration; patients must have serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP) within 14 days prior to registrationXx_NEWLINE_xXPatients must have complete history and physical examination within 28 days prior to registrationXx_NEWLINE_xXPatients must have baseline PET scan within 28 days prior to registration; note that images are submitted centrally for reviewXx_NEWLINE_xXPatients must have undergone an electrocardiogram (EKG) within 28 days prior to registrationXx_NEWLINE_xXPatients must have baseline skeletal survey to document lytic lesions, osteopenia or compression fracture within 28 days prior to registrationXx_NEWLINE_xXAt least 14 days and no more than 28 days must have elapsed between the last day of treatment on Arm 1 and registration to Arm 3Xx_NEWLINE_xXPrior DLI is allowed, however not within the 30 days before the 1st dose of ALT-803Xx_NEWLINE_xXAbility to be off prednisone and other immunosuppressive drugs for at least 14 days before first dose of study drugXx_NEWLINE_xXNo prior radiation therapy within the last 4 weeks, except as below \r\n* To the thoracic cavity, abdomen, or pelvis within 12 weeks before the first dose of study treatment, or has ongoing complications, or is without complete recovery to < grade 1 toxicity\r\n* To bone or brain metastasis within 14 days before the first dose of study treatment\r\n* To any other site(s) within 28 days before the first dose of study treatment\r\n* Prior radiation treatment may have included no more than 3000 centigray (cGy) to fields including substantial bone marrowXx_NEWLINE_xX> 10% lymphoplasmacytic cells (measured within 28 days prior to registration ORXx_NEWLINE_xXMeasurable disease defined as a quantitative IgM monoclonal protein of >500\n                  mg/dL obtained within 28 days prior to registrationXx_NEWLINE_xXPrior irradiation is allowed if > 28 days prior to registration have elapsed since\n             the date of last treatment.Xx_NEWLINE_xXModerate or severe symptomatic metastatic disease, defined as a requirement for treatment with opioid analgesics for cancer-related pain within 21 days prior to registrationXx_NEWLINE_xXPatients asking or who have had prior treatment with a drug like vorinostat (i.e., valproic acid) within the last 30 daysXx_NEWLINE_xXTreatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)Xx_NEWLINE_xXUrinalysis within 14 days demonstrating no evidence of a urinary tract infectionXx_NEWLINE_xXComplete history and physical examination noting in detail the exact size and location of any lesions that are detected on examination will be performed within 30 days prior to initiation of chemotherapyXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n* Myelosuppressive chemotherapy:  \r\n** Solid tumors: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** ALCL:\r\n*** Patients with ALCL who relapse while receiving standard maintenance chemotherapy will not be required to have a waiting period before enrollment onto this study\r\n*** Patients who relapse while they are not receiving standard maintenance therapy, must have fully recovered from all acute toxic effects of prior therapy; at least 14 days must have elapsed after the completion of cytotoxic therapy\r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody\r\n* Radiation therapy (XRT):  \r\n** Solid tumors: at least 14 days after local palliative XRT (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of metaiodobenzylguanidine (MIBG); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n** ALCL: at least 14 days after local palliative XRT (small port); at least 84 days must have elapsed if prior TBI, craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial BM radiation\r\n* Stem cell infusion without TBI: no evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant and >= 42 days for autologous stem cell infusion after iodine (I)131-MIBG therapy\r\n* Patients must not have received prior therapy with crizotinib\r\n* Prior anthracycline dose: patients with a total lifetime cumulative anthracycline dose of > 650 mg/m^2 at the time of enrollment are not eligible for Part B of the studyXx_NEWLINE_xXOther anti-neoplastic investigational agents currently or within 30 days prior to apheresis (i.e. start of protocol therapy)Xx_NEWLINE_xXMonoclonal antibody therapy administered within 30 days of the agent prior to apheresisXx_NEWLINE_xXAny of the following prior therapies:\r\n* Chemotherapy =< 28 days prior to registration\r\n* Mitomycin C/nitrosoureas =< 42 days prior to registration\r\n* Immunotherapy =< 28 days prior to registration\r\n* Biologic therapy =< 28 days prior to registration\r\n* Radiation therapy =< 28 days prior to registration\r\n* Radiation to > 25% of bone marrowXx_NEWLINE_xXPrior investigational therapy must be completed at least 30 days prior to study entryXx_NEWLINE_xXPretreatment lab values must be performed within 14 days of patient registration unless otherwise specified; other baseline studies must be performed within 30 days of registrationXx_NEWLINE_xXThe following pre-study tests should be obtained within 14 days prior to registration in accordance with good medical practice; results of these tests do not determine eligibility and minor deviations are acceptable if they do not impact patient safety in the judgment of the treating physician:Xx_NEWLINE_xXPatients must not have evidence of new CNS hemorrhage on baseline MRI obtained within 14 days prior to study enrollmentXx_NEWLINE_xXPRIOR TO STEP 1 REGISTRATION BUT WITHIN 56 DAYS PRIOR TO STEP 2 REGISTRATIONXx_NEWLINE_xXConsultation with a medical oncologist within 56 days prior to step 2 registrationXx_NEWLINE_xXStage T1N1-2, T2-3N0-2, according to the AJCC 7th edition staging, based upon the following minimum diagnostic work-up:\r\n* History/physical examination, with documentation of the patient’s weight, within 14 days prior to step 2 registration\r\n* Whole-body PET/CT scan within 56 days prior to step 2 registration (if only CT performed prior to step 1 registration)\r\n* Endoscopic ultrasound within 56 days prior to step 2 registration, unless the patient is found to have adenopathy per CT or whole-body PET/CT scan\r\n* Electrocardiogram (EKG) within 56 days prior to step 2 registration\r\n* Serum creatinine =< 2 x the upper limit or normal within 14 days prior to step 2 registrationXx_NEWLINE_xXAt least 7 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chairXx_NEWLINE_xXExpected survival if untreated less than 60 daysXx_NEWLINE_xXPrestudy history and physical must be obtained with 28 days prior to registrationXx_NEWLINE_xXPatients must have a complete history and physical examination within 28 days prior to registrationXx_NEWLINE_xXcytotoxic agents (e.g. Mitomycin C, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure which is permitted between 14 to 60 days prior to beginning study treatmentXx_NEWLINE_xXAgree not to try to become pregnant during the study and for 180 days after the final study administrationXx_NEWLINE_xXFemale subject must agree not to breastfeed at Screening and throughout the study period and for 60 days after the final study drug administration.Xx_NEWLINE_xXFemale subject must not donate ova starting at Screening and throughout the study period and for 180 days after the final study drug administration.Xx_NEWLINE_xXMale subject must not donate sperm starting at Screening and throughout the study period and 120 days after the final study drug administration.Xx_NEWLINE_xXPatients who can complete PRO forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I EQ-5D Questionnaire within 14 days prior to registration; NOTE: Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO studyXx_NEWLINE_xXRadiotherapy (RT) (At least 14 days from last local site RT prior to first dose of tazemetostat/At least 21 days from stereotactic radiosurgery prior to first dose of tazemetostat/At least 12 weeks from craniospinal, ? 50% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)Xx_NEWLINE_xXFor subjects with CNS involvement: Subjects must have deficits that are stable for a minimum of 14 days prior to enrollment, or seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of 7 days prior to enrollment NOTE: Subjects with leptomeningeal disease or brian tumors with positive cerebral spinal fluid cytology are eligible for this study. Subjects may receive glucocorticoids (at stable or tapering dose) to control CNS symptoms prior to enrollment; however, subjects should receive a stable or tapering dose for at least 7 days prior to enrollment.Xx_NEWLINE_xXPatient must have no plans to receive any other experimental therapy while on the protocol treatment; previous experimental therapy must have been completed at least 28 days prior to registrationXx_NEWLINE_xXPatients must have a complete physical examination and medical history within 28 days prior to registrationXx_NEWLINE_xXImmunostimulants within 4 weeks or immunosuppressants within 14 days prior to study drugXx_NEWLINE_xXFemale Subjects must agree to not breastfeed from the time of Screening and throughout the study period, and for 25 days after the final study drug administration.Xx_NEWLINE_xXAnti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.Xx_NEWLINE_xXPrestudy history and physical must be obtained within 28 days prior to registrationXx_NEWLINE_xXHas received sorafenib within 14 days of first dose of study drug.Xx_NEWLINE_xXSubject has had prior treatment with biologic antineoplastic agents less than 7 days before the first dose of lenalidomide. For agents that have known Adverse Events (AEs) occurring beyond 7 days after administration (ie, monoclonal antibodies), this period must be extended beyond the time during which acute AEs are known to occur.Xx_NEWLINE_xXSubjects who have completed sipuleucel-T (Provenge ®) treatment within 28 days of study drug initiation.Xx_NEWLINE_xXSubjects on 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) within 28 days of study drug initiation.Xx_NEWLINE_xXSubject that started a bone modifying agent (e.g. bisphosphonates, denosumab) ? 28 days of study drug initiation (note: ongoing bone modifying agents administered > 28 days are allowed).Xx_NEWLINE_xXSubjects who received systemic anticancer therapy or radiotherapy <14 days prior to their first day of study drug administration. (Hydroxyurea is allowed prior to enrollment and after the start of AG-120).Xx_NEWLINE_xXPatients must have a complete history and physical examination within 28 days prior to registrationXx_NEWLINE_xXTherapeutic or experimental monoclonal antibodies within 28 day or prior radiation therapy within 14 days of the first dose of study drug.Xx_NEWLINE_xXRegistration within 42 days of evidence of disease progressionXx_NEWLINE_xXTreatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144Xx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days with some exceptions.Xx_NEWLINE_xXDiscontinuation of all drugs used to treat underlying MF disease at least 7 days prior to baseline visitXx_NEWLINE_xXnegative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib id menopause induced by gonadotropin-releasing hormone (GnRH) agonist or radiationXx_NEWLINE_xXreceived treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectivelyXx_NEWLINE_xXUse of certain investigational therapies within 21 days prior to enrollmentXx_NEWLINE_xXPatients must have lactate dehydrogenase (LDH) performed within 42 days prior to registrationXx_NEWLINE_xXPatients who received an investigational agent (including AG-120 or AG-221) <14 days prior to their first day of study drug administration. In addition, the first dose of AG-881 should not occur before a period ?5 half-lives of the investigational agent (other than AG-120 or AG-221) has elapsed.Xx_NEWLINE_xXInvestigational medicinal product within the last 30 days prior to screeningXx_NEWLINE_xXInvestigational medicinal product within the last 30 days prior to screeningXx_NEWLINE_xXRequiring corticosteroids or anticonvulsants in the prior 60 daysXx_NEWLINE_xXPatients must discontinue previous EGFR-TKI at least 7 days prior to study enrollmentXx_NEWLINE_xXPerformed within 14 days of patient registration: Serum creatinine =< 1.5 x IULNXx_NEWLINE_xXConcurrent or prior use of immunosuppressive medication with 14 daysXx_NEWLINE_xXMinimum of 14 days elapsed since the end of any prior therapyXx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must satisfy the following criteria to be enrolled in the study (with the\n        enrollment date defined as the date in which the subject is assigned a cohort in Integrated\n        Response Technology [IRT]) and receive their first dose of luspatercept:\n\n          1. Subject is ?18 years of age at the time of signing the informed consent form (ICF).\n\n          2. Subject has Myeloproliferative neoplasm (MPN)-associated myelofibrosis (PMF, post-\n             Post-polycythemia vera myelofibrosis (PV MF), and/or Post-essential thrombocythemia\n             myelofibrosis (post-ET MF)) as confirmed from the most recent local bone marrow biopsy\n             report according to the World Health Organization 2016 criteria.\n\n          3. Subject has anemia defined as:\n\n               1. Cohorts 1 and 3A\n\n                    -  Obtain ? 3 Hemoglobin (Hgb) levels of ? 9.5 g/dL recorded on ? 3 different\n                       days, including the day of dosing, in the 84-day period immediately up to\n                       the C1D1 date. There must be ? 14 days in between each Hgb measurement. No\n                       subjects with an interval ? 42 days between hemoglobin measurements will be\n                       enrolled.\n\n                    -  There must not be any Red blood cell (RBC) transfusions within the 84-day\n                       period immediately up to the C1D1 date.\n\n               2. Cohorts 2 and 3B\n\n                    -  Average RBC-transfusion frequency: 2 to 4 RBC units/28 days over at least\n                       the 84 days immediately up to the C1D1 date. There must be no interval > 42\n                       days without ? 1 RBC-transfusion.\n\n                    -  Subjects must have a Hgb value of < 13 g/dL on C1D1 prior to luspatercept\n                       administration.\n\n                    -  Only RBC transfusions given when the Hgb ? 9.5 g/dL are scored in\n                       determining eligibility.\n\n                    -  RBC transfusions given because of bleeding, infection, or chemotherapy\n                       induced anemia are not scored in determining eligibility.\n\n          4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ? 2.\n\n          5. Subject is not anticipated during the 6 months from the C1D1 date to receive a\n             hematopoietic cell transplant.\n\n          6. A female of childbearing potential (FCBP) for this study is defined as a female who:\n             1) has achieved menarche at some point, 2) has not undergone a hysterectomy or\n             bilateral therapy does not rule out childbearing potential) for at least 24\n             consecutive months (ie, has had menses at any time in the preceding 24 consecutive\n             months). FCBP participating in the study must:\n\n               1. Have 2 negative pregnancy tests as verified by the Investigator prior to starting\n                  study therapy. She must agree to ongoing pregnancy testing during the course of\n                  the study, and after end of study treatment. This applies even if the subject\n                  practices true abstinence* from heterosexual contact.\n\n               2. Either commit to true abstinence* from heterosexual contact (which must be\n                  reviewed on a monthly basis and source documented) or agree to use, and be able\n                  to comply with, effective contraception** without interruption, 28 days prior to\n                  starting investigational product, during the study therapy (including dose\n                  interruptions), and for 12 weeks (approximately 5 times the mean terminal\n                  halflife of luspatercept based on multiple-dose pharmacokinetics [PK] data) after\n                  discontinuation of study therapy.\n\n          7. Male subjects must:\n\n             a. Practice true abstinence (which must be reviewed on a monthly basis) or agree to\n             use a condom during sexual contact with a pregnant female or a female of childbearing\n             potential while participating in the study, during dose interruptions and for at least\n             12 weeks (approximately 5 times the mean terminal half-life of luspatercept based on\n             multiple-dose PK data) following investigational product discontinuation, even if he\n             has undergone a successful vasectomy\n\n          8. Subject must understand and voluntarily sign an ICF prior to any study-related\n             assessments/procedures being conducted.\n\n          9. Subject is willing and able to adhere to the study visit schedule and other protocol\n             requirements.\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment (with the\n        enrollment date defined as the date in which the subject is assigned a cohort in Integrated\n        Response Technology (IRT)):\n\n          1. Subject use of hydroxyurea or other drugs with potential effects on hematopoiesis or\n             ongoing adverse events from previous treatment ? 112 days immediately up to the\n             enrollment date.\n\n             a. Systemic corticosteroids are permitted for nonhematological conditions providing\n             the subject is receiving a stable or decreasing dose for ? 84 days immediately up to\n             enrollment and is receiving a constant dose equivalent to ? 10 mg prednisone for the\n             28 days immediately up to enrollment.\n\n          2. Cohort 1 and 2 only: subjects treated with Janus kinase 2 gene (JAK2) inhibitors ? 112\n             days immediately up to the enrollment date or if anticipated/substantial likelihood\n             for subject to receive ruxolitinib within the first 168 days on the study.\n\n          3. Cohort 3 only: subjects not receiving a stable dose of ruxolitinib as part of their\n             standard-of-care therapy for 112 days immediately up to the enrollment date.\n\n          4. Subject use of ESAs or androgenic steroids ? 112 days immediately up to the enrollment\n             date.\n\n          5. Initiation of iron chelation therapy (ICT) or change with ICT dose within ? 112 days\n             up to the enrollment date.\n\n          6. Subject with anemia from iron deficiency, B12 and folate deficiencies, hemolytic\n             anemia, infection, or bleeding.\n\n          7. Pregnant or breastfeeding females.\n\n          8. Subject with blood myeloblasts ? 5%.\n\n          9. Subject with major surgery within 8 weeks up to the enrollment date. Subject must have\n             completely recovered from any previous surgery immediately up to the enrollment date.\n\n         10. Subject with prior history of malignancies, other than disease under study, unless the\n             subject has been free of the disease for ? 5 years. However, subject with the\n             following history/concurrent conditions is allowed:\n\n               -  Basal or squamous cell carcinoma of the skin\n\n               -  Carcinoma in situ of the cervix\n\n               -  Carcinoma in situ of the breast\n\n               -  Incidental histologic finding of prostate cancer (T1a or T1b using the tumor,\n                  nodes, metastasis [TNM] clinical staging system)\n\n         11. Subject with prior therapy of luspatercept or sotatercept.\n\n         12. Subject participation in any other clinical protocol or investigational trial that\n             involves administration of experimental therapy and/or therapeutic devices within 30\n             days immediately up to the enrollment date.\n\n         13. Subject with prior hematopoietic cell transplant.\n\n         14. Subject with any of the following laboratory abnormalities:\n\n               -  Neutrophils < 1 x 109/L\n\n               -  White blood count (WBC) > 100 x 109/L\n\n               -  Platelets\n\n                    -  Cohorts 1 and 2: < 25 x 109/L\n\n                    -  Cohort 3A and 3B: < 50 x 109/L\n\n                    -  All Cohorts: > 1000 x 109/L\n\n               -  Estimated glomerular filtration rate < 45 mL/min/1.73 m2 (via the 4-variable\n                  modification of diet in renal disease [Modification of diet in renal disease\n                  (MDRD)] formula)\n\n               -  Aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3.0 x upper\n                  limit of normal (ULN)\n\n               -  Direct bilirubin ? 2 x ULN\n\n                  o higher levels are acceptable if these can be attributed to active red blood\n                  cell precursor destruction within the bone marrow (ie, ineffective\n                  erythropoiesis)\n\n               -  Uncontrolled hyperthyroidism or hypothyroidism\n\n         15. Subject with stroke, deep venous thrombosis, pulmonary or arterial embolism within 6\n             months immediately up to the enrollment date.\n\n         16. Subject with diastolic blood pressure ? 90 mmHg or systolic blood pressure ? 140 mmHg\n             measured during the Screening Period despite appropriate treatment.\n\n         17. Subject with inadequately controlled heart disease and/or have a known left\n             ventricular ejection fraction <35%.\n\n         18. Subject with history of severe allergic or anaphylactic reactions or hypersensitivity\n             to recombinant proteins or excipients in the investigational product (see luspatercept\n             Investigator's Brochure (IB)).\n\n         19. Subject with uncontrolled systemic fungal, bacterial, or viral infection (defined as\n             ongoing signs/symptoms related to the infection without improvement despite\n             appropriate antibiotics, antiviral therapy, and/or other treatment).\n\n         20. Subject with human immunodeficiency virus (HIV), evidence of active infectious\n             Hepatitis B (HepB), and/or evidence of active Hepatitis C (HepC).\n\n         21. Subject with any significant medical condition, laboratory abnormality, psychiatric\n             illness, or is considered vulnerable by local regulations (eg, imprisoned or\n             institutionalized) that would prevent the subject from participating in the study.\n\n         22. Subject with any condition including the presence of laboratory abnormalities, which\n             places the subject at unacceptable risk if he/she were to participate in the study.\n\n         23. Subject with any condition or concomitant medication that confounds the ability to\n             interpret data from the study.\n\n         24. Subject on anticoagulant therapy not under appropriate control or subject not on a\n             stable dose of anticoagulant therapy for ? 8 weeks up to the enrollment date.\n\n         25. Subject on anagrelide within 28 days immediately up to the enrollment date.\n\n         26. Subject with a major bleeding event (defined as symptomatic bleeding in a critical\n             area or organ and/or bleeding causing a decrease in hemoglobin of ? 2g/dL or leading\n             to transfusion of ? 2 units of packed red cells) in the last 6 months prior to\n             enrollment.Xx_NEWLINE_xXPrior AML or ALL therapy (non-experimental) within 28 days of first dose of ONO-7475 (except those permitted in the protocol)Xx_NEWLINE_xXPatients who have received wide field radiotherapy ? 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to cycle 1 day 1 or those patients who have not recovered adequately from side effects of such therapyXx_NEWLINE_xXThrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapyXx_NEWLINE_xXNo active or recent hemoptysis (>= 1/2 teaspoon of bright red blood per episode) =< 30 days prior to registrationXx_NEWLINE_xXPrestudy history and physical must be obtained within 28 days prior to registrationXx_NEWLINE_xXPatients must have a complete physical examination and medical history within 28 days prior to registrationXx_NEWLINE_xXBilirubin =< 1.5 x ULN obtained within 28 days prior to registrationXx_NEWLINE_xXSubjects with a history of bleeding related to cancer under study requiring a medical intervention (eg, embolization procedure, RBC transfusion, or hospitalization) within 30 days of study enrollment (Treatment Groups B and C only).Xx_NEWLINE_xXStable or decreasing dose of corticosteroids within 5 days prior to study 5. enrollment.Xx_NEWLINE_xX? 28 days elapsed from the administration of any prior cytotoxic agents, except ? 14 days from vincristine, ? 21 days from procarbazine, and ? 42 days from nitrosureasXx_NEWLINE_xX? 14 days elapsed from administration of any non-cytotoxic agent (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid)Xx_NEWLINE_xXA minimum of 28 days must have elapsed from the day of surgery to first dose of the study drug. For core or needle biopsy, a minimum of 7 days must have elapsed prior to study entryXx_NEWLINE_xXPatients must not have received nitrosoureas or mitomycin-C within 42 days prior to sub-study registrationXx_NEWLINE_xXPrestudy history and physical exam must be obtained within 28 days prior to RE-TREATMENT registrationXx_NEWLINE_xXRefrain from egg cell and blood donation for 90 days after the final dose of durvalumab.Xx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion:Xx_NEWLINE_xXAre using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study and for 30 days after study drug discontinuation.Xx_NEWLINE_xXSerum creatinine =< IULN within 14 days prior to registrationXx_NEWLINE_xXCA19-9 must be performed within 14 days prior to registrationXx_NEWLINE_xXPrestudy history and physical must be obtained within 28 days prior to registrationXx_NEWLINE_xXPatient has an investigational medicinal product within the last 30 days prior to screening.Xx_NEWLINE_xXAgreement to use contraception during the study and for 90 days after the last dose of ACP-196 or 120 days after the last dose of pembrolizumab, if sexually active and able to bear or beget children.Xx_NEWLINE_xXNo prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosingXx_NEWLINE_xXRequiring corticosteroids or anticonvulsants in the prior 60 daysXx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days before the first dose of study drugsXx_NEWLINE_xXUse of any investigational drug within 14 days prior to the first dose of study drugXx_NEWLINE_xXThrombocytopenia (sustained for at least 21 days) within 14 days prior to randomizationXx_NEWLINE_xXUse of cytotoxic, chemotherapeutic, targeted or investigational agents/therapies, thrombopoiesis-stimulating agents (TSAs), erythropoiesis-stimulating agents (ESAs) and other red blood cell hematopoietic growth factors, and within 28 days prior to randomizationXx_NEWLINE_xXConcurrent use of iron-chelating agents, (except for subjects on a stable or decreasing dose for at least 8 weeks (56 days) prior to randomization), corticosteroid (except for subjects on a stable or decreasing dose for ? 1 week prior to randomization for medical conditions other than MDS)Xx_NEWLINE_xXComplete history and physical examination including weight and Zubrod status within 31 days of study entry (or within 31 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)Xx_NEWLINE_xXComplete blood count (CBC)/differential obtained within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)Xx_NEWLINE_xXSerum total bilirubin =< twice the institutional upper limit of normal (ULN) within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)Xx_NEWLINE_xXCreatinine levels =< twice the institutional upper limit of normal within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)Xx_NEWLINE_xXSerum glutamic oxaloacetic transaminase (SGOT) must be =< 2.5 x institutional ULN within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)Xx_NEWLINE_xXMonoclonal antibody (ies) At least 28 daysXx_NEWLINE_xXAt least 14 days for stereotactic radiosurgeryXx_NEWLINE_xXAutologous hematopoietic cell infusion after high dose therapy At least 60 daysXx_NEWLINE_xXIs unwilling to adhere to contraception criteria from time of enrollment in study to at least 30 days after last dose of IP.Xx_NEWLINE_xXDiscontinued all prior treatment for cancer at least 14 days prior to initial dose of study treatment.Xx_NEWLINE_xXParticipant has received radiation therapy to lung greater than 30 Gy within 6 months, or antineoplastic biologic therapy within 21 days, or major surgery within 21 days, or tyrosine kinase inhibitor therapy within 7 days, or palliative radiation within 7 days of the first dose of study medication.Xx_NEWLINE_xXPatients must have completed systemic therapy at least 14 days prior to registration, any surgical procedure must have been performed at least 14 days prior to registration, and radiation therapy must be completed at least 7 days prior to registration; patients must have recovered from major side effects of prior therapies or procedures in the opinion of the local site investigator prior to registrationXx_NEWLINE_xXPatients must have CA19-9 obtained within 14 days prior to registration; if CA19-9 is normal a carcinoembryonic antigen (CEA) must be tested within 14 days prior to registrationXx_NEWLINE_xXPatients must have a complete physical examination and medical history within 28 days prior to registrationXx_NEWLINE_xXUse of any of the following within 28 days prior to the first dose of IP:Xx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion:Xx_NEWLINE_xXAny investigational therapy within 28 days prior to the first dose of IP.Xx_NEWLINE_xXAny investigational therapy within 28 days prior to the first dose of IP.Xx_NEWLINE_xXPotassium =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registrationXx_NEWLINE_xXMagnesium =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registrationXx_NEWLINE_xXSodium =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registrationXx_NEWLINE_xXPhosphorus =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registrationXx_NEWLINE_xXCompleted treatment with systemic corticosteroid or immune-modulators < 30 days prior to registration;Xx_NEWLINE_xXPatients who have received any investigational products, antineoplastic therapies, or radiotherapy within 14 days prior to registration are not eligible; NOTE: patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea through cycle 1 of protocol treatment; if the platelet count remains above 1 million after cycle 1, hydroxyurea can be used at the treating physician’s discretion, if the platelets are 1000 x 10^9/L, or more, or if there are symptoms from thrombocytosisXx_NEWLINE_xXPatients who have had grade 2 or higher diarrhea, despite optimal antidiarrheal supportive care, within 7 days prior to registration are not eligibleXx_NEWLINE_xXPrior allogeneic bone marrow progenitor cell transplant within 100 days or on active immunosuppression for graft versus host disease (GVHD) treatment or prophylaxis within 28 days prior to enrollmentXx_NEWLINE_xXInclusion Criteria\n\n        PART 1\n\n          -  Has locally advanced or metastatic ccRCC and has progressed during treatment with at\n             least one prior therapeutic regimen\n\n          -  Is of age ? 18 years\n\n          -  Has a life expectancy of ? 3 months\n\n          -  Has adequate organ function\n\n          -  If a female patient, must be surgically sterile, post-menopausal, or must agree to use\n             physician-approved method of birth control during the study and for a minimum of 30\n             days after the last study drug administration, or if a male patient with a female\n             partner, must agree to use physician-approved method of birth control during the study\n             and for a minimum of 30 days after the last study drug administration\n\n          -  Able to swallow oral medications\n\n        PART 2 - In addition to PART 1\n\n          -  Received no more than three prior systemic treatment regimens in the advanced or\n             metastatic setting\n\n          -  Must have received at least one but not more than two prior anti-angiogenic therapy\n             regimens\n\n        PART 3 - In addition to PART 1\n\n        • Must have received at least one vascular endothelial growth factor receptor (VEGFR)\n        targeting tyrosine kinase inhibitor\n\n        Exclusion Criteria\n\n        PART 1\n\n          -  Has a history of untreated brain metastasis or history of leptomeningeal disease or\n             spinal cord compression\n\n          -  Has failed to recover from the reversible effects of prior anticancer therapy\n\n          -  Has uncontrolled or poorly controlled hypertension\n\n          -  Is receiving warfarin anticoagulant therapy or expected to require warfarin\n\n          -  Has had any major cardiovascular event within 6 months prior to study drug\n             administration\n\n          -  Has any other clinically significant cardiac, respiratory, or other medical or\n             psychiatric condition that might interfere with participation in the trial or\n             interfere with the interpretation of trial results\n\n          -  Has had major surgery within 4 weeks before first study drug administration\n\n          -  Has known HIV\n\n          -  Has an active infection requiring systemic treatment\n\n          -  Is participating in another therapeutic clinical trial\n\n        PART 2 - In addition to PART 1\n\n          -  Has received prior immunotherapy\n\n          -  Has any active or recent history of a known or suspected autoimmune disease\n\n        PART 3 - In addition to PART 1\n\n          -  Gastrointestinal (GI) disorders\n\n          -  Any history of congenital long QT syndromeXx_NEWLINE_xXInclusion\n\n          -  Has read and understands the informed consent form (ICF) and has given written IC\n             prior to any study specific procedures.\n\n          -  Histologic or cytologic diagnosis of epithelial ovarian, fallopian tube, or primary\n             peritoneal cancer.\n\n          -  Progressed within 6 months of completing at least 4 cycles of a first-line\n             platinum-containing regimen for Stage III/IV disease. Patients with refractory disease\n             (progression during platinum-containing therapy) are ineligible.\n\n          -  No more than 2-4 prior treatment regimens for Stage III/IV disease, defined as\n             investigational, chemotherapy, hormonal, biologic, or targeted therapy.\n\n          -  Prior doxorubicin (or other anthracycline) at a cumulative dose of ? 360 mg/m² or\n             cumulative epirubicin dose of ? 720 mg/m² (calculated using doxorubicin equivalent\n             doses: 1 mg of doxorubicin = 1 mg PLD = 0.3 mg mitoxantrone = 0.25 mg idarubicin).\n             Subjects without any prior anthracycline exposure can also be included. Applies to Arm\n             D only.\n\n          -  At least 1 measurable lesion according to RECIST v1.1.\n\n          -  Any prior palliative radiation therapy must be completed at least 7 days prior to\n             start of study treatment and patients must have recovered from any acute adverse\n             effects prior to start of study treatment.\n\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 - 1.\n\n          -  Baseline Laboratory Values:\n\n               1. ANC ?1500/?L\n\n               2. HgB ? 9 g/dL with no blood transfusions in the past 28 days\n\n               3. Platelets ? 100,000/?L\n\n               4. ALT & AST ?3 x ULN or ?5 x ULN if known hepatic metastases\n\n               5. Serum bilirubin within normal limits (WNL) or ?1.5 x the ULN in patients with\n                  liver metastases; or total bilirubin ?3.0 x ULN with direct bilirubin WNL in\n                  patients with well documented Gilbert's Syndrome.\n\n               6. Serum creatinine ?1.5 x the ULN and a calculated creatinine clearance (CrCl) ?45\n                  mL/min by the Cockcroft-Gault method.\n\n          -  Left ventricular ejection fraction (LVEF) WNL of the institution as determined by\n             multiple uptake gated acquisition (MUGA) or echocardiography (ECHO) (applies to Arm D\n             only).\n\n          -  Female patients, ?18, (not of childbearing potential and fertile female patients of\n             childbearing potential) who agree to use adequate contraceptive measures from 2 weeks\n             prior to the study and until 1 month after study treatment discontinuation, who are\n             not breastfeeding, and who have a negative serum or urine pregnancy test within 72\n             hours prior to start.\n\n          -  Predicted life expectancy ? 12 weeks\n\n        Exclusion\n\n          -  Use of a study drug (approved or investigational drug therapy) ?21 days or 5\n             half-lives (whichever is shorter) prior to the first dose of study treatment. For\n             study drugs for which 5 half-lives is ?21 days, a minimum of 10 days between\n             termination of the study drug and administration of study treatment is required.\n\n          -  Major surgical procedures ? 28 days of beginning study, or minor surgical procedures ?\n             7 days. No waiting period following port-a-cath placement, or any other central venous\n             access placement.\n\n          -  Grade >1 toxicity from prior therapy (except alopecia or anorexia).\n\n          -  Known malignant CNS disease other than neurologically stable, treated brain\n             metastases, defined as metastasis having no evidence of progression or haemorrhage\n             after treatment for at least 2 weeks (including brain radiotherapy). Must be off any\n             systemic corticosteroids for the treatment of brain metastases for at least 14 days\n             prior to enrolment.\n\n          -  Patient has had prescription or non-prescription drugs or other products (i.e.\n             grapefruit juice) known to be sensitive CYP3A4 substrates or CYP3A4 substrates with a\n             narrow therapeutic index, or to be moderate to strong inhibitors or inducers of CYP3A4\n             which cannot be discontinued 2 weeks prior to Day 1 of dosing and withheld throughout\n             the study until 2 weeks after last dose of study drug.\n\n          -  Caution should be exercised when inhibitors or substrates of P-gP, substrates of\n             CYP1A2 with a narrow therapeutic range, sensitive substrates of CYP2C19 or CYP2C19\n             substrates with a narrow therapeutic range are administered with AZD1775.\n\n          -  Herbal medications should be discontinued 7 days prior to the first dose of study\n             treatment.\n\n          -  Any of the following cardiac diseases currently or within the last 6 months as defined\n             by New York Heart Association (NYHA) ? Class 2:\n\n               1. Unstable angina pectoris\n\n               2. Congestive heart failure\n\n               3. Acute myocardial infarction\n\n               4. Conduction abnormality not controlled with pacemaker or medication\n\n               5. Significant ventricular or supraventricular arrhythmias (patients with chronic\n                  rate controlled atrial fibrillation in the absence of other cardiac abnormalities\n                  are eligible).\n\n          -  AZD1775 should not be given to patients who have a history of Torsades de pointes\n             unless all risk factors that contributed to Torsades have been corrected. AZD1775 has\n             not been studied in patients with ventricular arrhythmias or recent myocardial\n             infarction.\n\n          -  Corrected QT interval (QTc) >470 msec at study entry or congenital long QT syndrome.\n\n          -  Pregnant or lactating.\n\n          -  Serious active infection at the time of enrolment, or another serious underlying\n             medical condition that would impair the patient's ability to receive study treatment.\n\n          -  Presence of other active cancers, or history of treatment for invasive cancer within 3\n             years. Patients with Stage I cancer who have received definitive local treatment\n             within 3 years, and whom are considered unlikely to recur, are eligible. Patients with\n             previously treated in-situ carcinoma (i.e., non-invasive) are eligible, as are\n             patients with prior non-melanoma skin cancers.Xx_NEWLINE_xXTreatment with any investigational drug within 28 days before randomisation.Xx_NEWLINE_xXInclusion Criteria:\n\n        - Subjects must satisfy the following criteria to be enrolled in the study:\n\n          1. Adults (age ? 18 years at the time of signing the ICD) with documented diagnosis of MM\n             and measurable disease (serum M-protein ? 0.5 g/dL or urine M-protein ? 200 mg/24\n             hours).\n\n          2. Subjects enrolling in Cohort A (Pom+LD-dex) must have received 2 prior treatment lines\n             of anti-myeloma therapy. Subjects enrolling in Cohort B (Pom+Dara+LD-dex) must have\n             received 1 or 2 prior treatment lines of anti-myeloma therapy.\n\n          3. All subjects must have received prior treatment with LEN or a LEN-containing regimen\n             for at least 2 consecutive cycles as the most recent treatment regimen.\n\n          4. All subjects must have documented disease progression during or after their last\n             antimyeloma therapy.\n\n          5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status\n             score of 0, 1, or 2.\n\n          6. Subjects must understand and voluntarily sign an ICD prior to any study related\n             assessments/procedures being conducted.\n\n          7. Subjects must be able to adhere to the study visit schedule and other protocol\n             requirements.\n\n          8. All subjects must provide an adequate bone marrow sample at screening that\n             definitively evaluates the presence or absence of myelodysplastic changes.\n\n          9. Females with child-bearing potential (FCBP†) must agree to use 2 reliable forms of\n             contraception* simultaneously or practice complete abstinence from heterosexual\n             contact for at least 28 days before starting study drug, while participating in the\n             study (including during dose interruptions), and for at least 28 days after study\n             treatment discontinuation and must agree to regular pregnancy testing during this\n             timeframe. For subjects enrolled in Cohort B, pregnancy prevention and testing will\n             continue until 3 months after last dose of daratumumab.\n\n         10. Females must agree to abstain from breastfeeding during study participation and 28\n             days after study drug discontinuation. Female subjects enrolled in Cohort B must agree\n             to abstain from breastfeeding and donating eggs during study participation and until 3\n             months after last dose of daratumumab.\n\n         11. Males must agree to use a latex condom during any sexual contact with FCBP while\n             participating in the study and for 28 days following discontinuation from this study,\n             even if he has undergone a successful vasectomy. Male subjects enrolled in Cohort B\n             must agree to use a latex condom during any sexual contact with FCBP while\n             participating in the study and until 3 months after last dose of daratumumab.\n\n         12. Males must also agree to refrain from donating semen or sperm during the treatment\n             phase and for 28 days after discontinuation from this study treatment. Male subjects\n             enrolled in Cohort B must also agree to refrain from donating semen or sperm during\n             the treatment phase and until 3 months after last dose of daratumumab.\n\n         13. All subjects must agree to refrain from donating blood while on study therapy and for\n             28 days after discontinuation from this study treatment.\n\n         14. All subjects must agree not to share medication.\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from study enrollment:\n\n          1. Any of the following laboratory abnormalities:\n\n               -  Absolute neutrophil count < 1,000/?L\n\n               -  Platelet count < 75,000/?L for subjects in whom < 50% of bone marrow nucleated\n                  cells are plasma cells; or a platelet count < 30,000/?L for subjects in whom ?\n                  50% of bone marrow nucleated cells are plasma cells.\n\n               -  Severe renal impairment (Creatinine Clearance [CrCl] < 30 mL/min) requiring\n                  dialysis.\n\n               -  Corrected serum calcium > 11.5 mg/dL (> 2.8 mmol/L)\n\n               -  Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior red blood cell transfusion or\n                  recombinant human erythropoietin use is permitted)\n\n               -  Serum SGOT/AST or SGPT/ALT > 3.0 x the upper limit of normal (ULN)\n\n               -  Serum total bilirubin > 2.0 mg/dL (34.2 ?mol/L); or > 3.0 x ULN for subjects with\n                  hereditary benign hyperbilirubinemia\n\n          2. Prior history of malignancies, other than MM, unless the subject has been free of the\n             disease for ? 5 years. Allowed exceptions include the following:\n\n               -  Basal or squamous cell carcinoma of the skin\n\n               -  Carcinoma in situ of the cervix or breast\n\n               -  Incidental histological finding of prostate cancer (TNM [tumor, nodes,\n                  metastasis] stage of T1a or T1b)\n\n          3. Previous therapy with pomalidomide or daratumumab\n\n          4. Hypersensitivity to thalidomide, LEN, or dex (this includes ? Grade 3 rash during\n             prior thalidomide or LEN therapy)\n\n          5. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem\n             cell transplant less than 12 months prior to initiation of study treatment and who\n             have not discontinued immunosuppressive treatment for at least 4 weeks prior to\n             initiation of study treatment and are currently dependent on such treatment.\n\n          6. Subjects with any one of the following:\n\n               -  Congestive heart failure (NY Heart Association Class III or IV)\n\n               -  Myocardial infarction within 12 months prior to starting study treatment\n\n               -  Unstable or poorly controlled angina pectoris, including Prinzmetal's variant\n                  angina pectoris\n\n          7. Subjects who received any of the following within 14 days of initiation of study\n             treatment:\n\n               -  Major surgery (kyphoplasty is not considered major surgery)\n\n               -  Use of any anti-myeloma drug therapy\n\n          8. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer)\n             of treatment, unless approved by the sponsor.\n\n          9. Incidence of gastrointestinal disease that may significantly alter the absorption of\n             Pomalidomide.\n\n         10. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment\n\n         11. Any serious medical condition, laboratory abnormality, or psychiatric illness that\n             would prevent the subject from signing the ICD\n\n         12. Pregnant or breastfeeding females\n\n         13. Known human immunodeficiency virus (HIV) positivity; active infectious hepatitis A, B,\n             or C; or chronic hepatitis B or C\n\n         14. For subjects enrolling in Cohort B - Subject has known allergies, hypersensitivity to\n             mannitol, corticosteroids, monoclonal antibodies or human proteins, or their\n             excipients (refer to the Daratumumab IB), or known sensitivity to mammalian-derived\n             products.Xx_NEWLINE_xXDigital rectal exam within 90 days of registration on studyXx_NEWLINE_xXPrior therapy for prostate cancer (exceptions: luteinizing hormone-releasing hormone [LHRH] agonist or antagonist may have been initiated within 30 days prior to enrollment; bicalutamide may have been given within 60 days of enrollment as long as it has been stopped at least 7 days before enrollment and total duration was no longer than 30 days; previous alpha-reductase inhibitor use allowed IF patient has not been taking for at least 30 days prior to abiraterone acetate initiation, OR if alpha reductase inhibitor was not used as a primary treatment of prostate cancer and the PSA on alpha-reductase inhibitor remains within eligibility when doubledXx_NEWLINE_xXPrior treatments usage as defined: A) Use of an investigational anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of the investigational products:; B) A minimum of 14 days between termination of the investigational drug and administration of GSK525762; C) Any therapy related toxicities must also have resolved to Grade 1 or less. Note that an investigational drug is defined as a drug without an approved oncologic indication; D) Chemotherapy, radiotherapy, anti-neoplastic antibody or targeted therapy or immunotherapy within 14 days, major surgery within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of the investigational product. Anti-androgen (e.g., bicalutamide) therapies for prostate cancer must be stopped 4 weeks prior to enrollment. Second line hormone therapies such as enzalutamide, abiraterone, or orteronel should be stopped 2 weeks prior to enrollment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone (up to 10 mg/day) and still be eligible for this study.Xx_NEWLINE_xXHemoptysis >1 teaspoon in 24 hours within the last 28 days.Xx_NEWLINE_xXReceived other investigational agents within 30 days prior to the start of the conditioning regimenXx_NEWLINE_xXPretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 28 days prior to registration to S0919; specimens must be submitted to the site’s preferred cytogenetics laboratoryXx_NEWLINE_xXPatients must have complete history and physical examination within 28 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< 2.0 x IULN within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert’s syndrome or hemolysis and not to liver dysfunctionXx_NEWLINE_xXInclusion Criteria:\n\n        In order to be eligible for participation in this trial, the patient must:\n\n          1. Have histologically or cytologically confirmed small cell lung cancer. Confirmation\n             will be done at each participating site.\n\n          2. Have relapsed or progressed after only one prior chemotherapy regimen, which must have\n             been an etoposide-platinum doublet. Eligible patients will be defined as follows:\n\n             \Sensitive\ Disease: Patients who had one previous line of chemotherapy and relapsed\n             after > 60 days of completion of treatment.\n\n             \Refractory\ Disease: Patients with no response to first-line chemotherapy or\n             progression >60 days after completing treatment.\n\n          3. Be ? 18 years of age on day of signing informed consent.\n\n          4. Have a life expectancy of at least 3 months.\n\n          5. Have a performance status of ? 1 on the ECOG Performance Scale.\n\n          6. Have measurable disease based on RECIST 1.1.\n\n          7. Have a tumor tissue specimen available from either a core or excisional biopsy. The\n             tumor specimen should be of adequate size and tumor cellularity to perform whole exome\n             sequencing and immunohistochemistry. In subjects for whom newly obtained samples\n             cannot be obtained (e.g. tumor inaccessible or safety concern), archived tissue may be\n             submitted, if it otherwise satisfies all specimen criteria. Archival samples must have\n             been obtained within 42 days prior to signing consent (please refer to section 12.1 of\n             protocol).\n\n          8. Demonstrate adequate organ function as defined in Table 1.\n\n             Table 1. Adequate Organ Function Laboratory Values System Laboratory Value\n             Hematological Absolute neutrophil count (ANC) ?1,500 /mcL Platelets ?100,000 / mcL\n             Hemoglobin ?8 g/dL (without transfusion) Renal Serum creatinine\n\n             OR\n\n             Glomerular Filtration Rate (GFR) ?1.5 X upper limit of normal (ULN)\n\n             OR\n\n             GFR ?60 mL/min* for patient with creatinine levels > 1.5 X institutional ULN Hepatic\n             Serum total bilirubin ? 1.5 X ULN\n\n             OR\n\n             Direct bilirubin ? ULN for patients with total bilirubin levels > 1.5 ULN AST (SGOT)\n             and ALT (SGPT) ? 2.5 X ULN\n\n             OR\n\n             ? 5 X ULN for patients with liver metastases Albumin ? 2.5 mg/dL\n\n             *GFR should be calculated per institutional standards.\n\n          9. Female patients of childbearing potential should have a negative urine or serum\n             pregnancy within 72 hours of starting treatment. If the urine test is positive or\n             cannot be confirmed as negative, a serum pregnancy test will be required.\n\n         10. Female patients of childbearing potential must be willing to an adequate method of\n             contraception as outlined in Section 14.4.1 - Contraception for the course of the\n             study through 120 days after the last dose of study medication (see Section 13.4.1).\n             Patients of childbearing potential are those who have not been surgically sterilized\n             or have not been free from menses for > 1 year.\n\n             Note: Abstinence is acceptable if this is the usual lifestyle and preferred\n             contraception for the subject.\n\n         11. Male patients must agree to use an adequate method of contraception as outlined in\n             Section 14.4.1 - Contraception - starting with the first dose of study therapy through\n             120 days after the last dose of study therapy. Note: Abstinence is acceptable if this\n             is the usual lifestyle and preferred contraception for the subject.\n\n        Exclusion Criteria:\n\n          -  The patient must be excluded from participating in the trial if the patient:\n\n               1. Is currently participating in or has participated in a study of an\n                  investigational agent or using an investigational device within 14 days of the\n                  first dose of treatment.\n\n               2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or\n                  any other form of immunosuppressive therapy within 7 days prior to the first dose\n                  of trial treatment.\n\n               3. Has had a prior monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or\n                  who has not recovered (i.e., ? Grade 1 or at baseline) from adverse events due to\n                  agents administered more than 14 days earlier.\n\n               4. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy\n                  within 2 weeks prior to study Day 1 or who has not recovered (i.e., ? Grade 1 or\n                  at baseline) from adverse events due to a previously administered agent.\n\n                  Note: Patients with ? Grade 2 neuropathy or ? Grade 2 alopecia are an exception\n                  to this criterion and may qualify for the study.\n\n               5. Has undergone major surgery, he/she must have recovered adequately from the\n                  toxicity and/or complications from the intervention prior to starting therapy.\n\n               6. Has a known additional malignancy that is progressing or requires active\n                  treatment.\n\n               7. Has known active central nervous system (CNS) metastases. Patients with\n                  previously treated brain metastases may participate provided they are stable\n                  (without evidence of progression by imaging for at least four weeks prior to the\n                  first dose of trial treatment and any neurologic symptoms have returned to\n                  baseline), have no evidence of new or enlarging brain metastases, and are not\n                  using steroids for at least 7 days prior to trial treatment.\n\n               8. Has known carcinomatous meningitis.\n\n               9. Has an active autoimmune disease requiring systemic treatment in the past 2 years\n                  or a documented history of clinically severe autoimmune disease, or a syndrome\n                  that requires systemic steroids or immunosuppressive agents. Patients with\n                  vitiligo or resolved childhood asthma/atopy would be an exception to this rule.\n                  Patients that require intermittent use of bronchodilators or local steroid\n                  injections would not be excluded from the study. Patients with hypothyroidism\n                  stable on hormone replacement or Sjorgen's syndrome will not be excluded from the\n                  study.\n\n              10. Has evidence of interstitial lung disease, or history of (non-infectious)\n                  pneumonitis that required steroids, or current pneumonitis.\n\n              11. Has an active infection requiring systemic therapy.\n\n              12. Has a history or current evidence of any condition, therapy, or laboratory\n                  abnormality that might confound the results of the trial, interfere with the\n                  patient's participation for the full duration of the trial, or is not in the best\n                  interest of the patient to participate, in the opinion of the treating\n                  investigator.\n\n              13. Has known psychiatric or substance abuse disorders that would interfere with\n                  cooperation with the requirements of the trial.\n\n              14. Is pregnant or breastfeeding, or expecting to conceive or father children within\n                  the projected duration of the trial, starting with the pre-screening or screening\n                  visit through 120 days after the last dose of trial treatment.\n\n              15. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-CD137, or\n                  anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including\n                  ipilimumab or any other antibody or drug specifically targeting T-cell\n                  co-stimulation or checkpoint pathways).\n\n              16. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n\n              17. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA\n                  [qualitative] is detected).\n\n              18. Has received a live vaccine within 30 days prior to the planned first dose of\n                  study therapy.\n\n                  Note: Seasonal influenza vaccines for injection are generally inactivated flu\n                  vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®)\n                  are live attenuated vaccines, and are not allowed.\n\n              19. Has a known history of active TB (Bacillus Tuberculosis).\n\n              20. Hypersensitivity to pembrolizumab or any of its excipients.Xx_NEWLINE_xXHistory/physical examination within 30 days prior to registrationXx_NEWLINE_xXReceived anti-neoplastic monoclonal antibodies within 30 days of the first dose of study drug.Xx_NEWLINE_xXFemale subject must agree not to breastfeed starting at Screening and throughout the study period, and for 60 days after the final study drug administration.Xx_NEWLINE_xXFemale subject must not donate ova starting at Screening and throughout the study period, and for 180 days after the final study drug administration.Xx_NEWLINE_xXMale subject must not donate sperm starting at Screening and throughout the study period and, for 120 days after the final study drug administration.Xx_NEWLINE_xXCryoablation should be performed within 14 days of screening visitXx_NEWLINE_xXInclusion Criteria:\n\n        A subject must satisfy all of the following criteria to be considered for inclusion in the\n        study:\n\n          -  Subjects with histologically or cytologically-confirmed diagnosis of cancer that is\n             recurrent, metastatic, or persistent, who have relapsed from or are refractory to\n             treatment and who also meet the following corresponding requirements for the cohort or\n             phase of the study into which they will enroll:\n\n               -  Dose-escalation Phase: Subjects with advanced solid tumors (any tumor type)\n                  considered to have no standard-of-care treatment for their malignancy with a\n                  curative intent, either as initial therapy or after progressing to prior\n                  therapies; subjects who have been treated previously with a CSF1R inhibitor or an\n                  anti PD1/PDL1 inhibitor may enroll.\n\n               -  Expansion Phase: Subjects with advanced melanoma, non-small-cell lung cancer\n                  (non-squamous; EGFR, ALK wild type), squamous cell carcinoma of the head and\n                  neck, ovarian cancer, or gastrointestinal stromal tumor.\n\n          -  Subjects with melanoma must have a histologically confirmed diagnosis of stage III\n             disease not amenable to local therapy. Melanoma subjects may have received any number\n             of prior lines of therapy for metastatic disease and must have measurable disease per\n             RECISTv1.1. Subjects with melanoma who have received prior treatment with a BRAF/MEK\n             inhibitor are acceptable candidates.\n\n          -  Expansion cohorts: Subjects must have relapsed or been refractory to standard\n             treatment. NSCLC, SCCHN, and Melanoma must show primary progression with\n             antiPD1/anti-PDL1 therapy. They must have tumor accessible for sequential biopsy (core\n             needle biopsy or excision required) and be willing to provide on study tumor tissue\n             biopsy. Subjects for whom newly obtained samples cannot be obtained (e.g. inaccessible\n             or patient safety concern) may submit an archived specimen only upon agreement from\n             the Sponsor.\n\n          -  ECOG performance status 0 or 1.\n\n          -  Adequate organ function as demonstrated by laboratory values.\n\n        Exclusion Criteria:\n\n        A subject who meets any of the following criteria will be disqualified from entering the\n        study:\n\n          -  Disease that is suitable for local therapy administered with curative intent.\n\n          -  Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other\n             form of immunosuppressive therapy within 7 days prior to the first dose of study\n             treatment.\n\n          -  Is currently participating and receiving study therapy or has participated in a study\n             of an investigational agent and received study therapy or used an investigational\n             device within 28 days prior to the first dose of study treatment.\n\n          -  Has had monoclonal antibody within 28 days of first dose of study treatment or has not\n             recovered from AEs due to agents administered more than 28 days earlier.\n\n          -  Has had chemotherapy, targeted small molecule therapy, or radiation therapy within 14\n             days prior to first dose of study treatment or who has not recovered from AEs due to a\n             previously administered agent.\n\n               -  Note: Subjects with ? Grade 2 neuropathy or ? Grade 2 alopecia are an exception\n                  to this criterion and may qualify for the study.\n\n               -  Note: If a subject received major surgery, he or she must have recovered\n                  adequately from the toxicity and/or complications from the intervention prior to\n                  starting study treatment.\n\n          -  Has received transfusion of blood products (including platelets or red blood cells\n             [RBC]) or administration of colony stimulating factors (including granulocyte\n             colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, or\n             recombinant erythropoietin) within 28 days prior to Day 1.\n\n          -  Evidence of interstitial lung disease or active, noninfectious pneumonitis.\n\n          -  Has a known additional malignancy that is progressing or requires active treatment.\n             Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the\n             skin that has undergone potentially curative therapy, in situ cervical cancer and\n             isolated elevation of prostate-specific antigen. Subjects with a completely treated\n             prior malignancy with no evidence of disease for ? 2 years are eligible.\n\n          -  For Expansion cohort subjects who have previously received an anti-PD-1, anti-PD-L1,\n             or anti?PD-L2 agent or has previously participated in pembrolizumab clinical trials\n             are excluded, except the following tumor types Melanoma, NSCLC and SCCHN (who must\n             show primary progression to anti-PD1/anti-PDL1 therapy).\n\n          -  Radiation therapy within 14 days of first dose of study treatment.\n\n          -  Has active autoimmune disease that has required systemic treatment in past 2 years\n             (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive\n             drugs). Replacement therapy is not considered a form of systemic treatment.\n\n          -  Has an active infection requiring systemic therapy.\n\n          -  Has known central nervous system metastases and/or carcinomatous meningitis.\n\n             o Note: Subjects with previously treated brain metastases may participate if they meet\n             the following criteria: 1) are stable for at least 28 days prior to the first dose of\n             study treatment and if all neurologic symptoms returned to baseline); 2) have no\n             evidence of new or enlarging brain metastases; and 3) have not been using steroids for\n             at least 7 days prior to first dose of study treatment. This exception does not\n             include carcinomatous meningitis, which is excluded regardless of clinical stability.\n\n          -  Uncontrolled intercurrent illness.\n\n          -  Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant\n             small bowel resection that would preclude adequate absorption.\n\n          -  QT interval corrected using Fridericia's formula (QTc) ? 450 msec (males) or ? 470\n             msec (females) at Screening.\n\n          -  Congenital long QT syndrome or patients taking concomitant medications known to\n             prolong the QT interval.\n\n          -  Major surgery within 28 days prior to first dose of study treatment.\n\n          -  Has received a live vaccine administered within 30 days prior to first dose of study\n             treatment.\n\n          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality\n             that might confound the results of the trial, interfere with the subject's\n             participation for the full duration of the trial, or is not in the best interest of\n             the subject to participate, in the opinion of the treating investigator.\n\n          -  Active and clinically significant bacterial, fungal or viral infection, including\n             hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus\n             (HIV) or acquired immunodeficiency syndrome related illness (HIV testing is not\n             required), including subjects who have an active infection requiring systemic therapy.\n\n          -  Any of the following within 48 weeks (~1 year) prior to first dose of study treatment:\n             myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft,\n             symptomatic congestive heart failure, cerebrovascular accident or transient ischemic\n             attack.\n\n          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the\n             projected duration of the trial, starting with the screening visit through 120 days\n             after the last dose of study treatment.\n\n          -  Has known psychiatric or substance abuse disorders that would interfere with\n             cooperation with the requirements of the trial.\n\n          -  Has had prior exposure to PLX3397.Xx_NEWLINE_xXPatients who have, within 14 days prior to Day 1 dosing:Xx_NEWLINE_xXSubjects with a history of seizures must be on a stable dose of anti-epileptic drugs (AEDs) and without seizures for 14 days prior to enrollment in patients enrolled prior to Amendment 2. Subjects enrolled after Amendment 2 is approved with a history of seizures must be on a stable dose of anti-epileptic drugs (AEDs) for 7 days prior to enrollment.Xx_NEWLINE_xXAnti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 14 days of the first dose of BBI608, except for BBI608 for which a washout period is not required.Xx_NEWLINE_xXPatients planning to take a vacation for 7 or more consecutive days during the course of the study.Xx_NEWLINE_xXPatients must have at least one metastatic lesion that can be followed on baseline imaging obtained no more than 28 days prior to beginning study therapy. Baseline and follow up radiological disease assessments must include bone scans performed with 99mTc labelled diphosphonatesXx_NEWLINE_xXContraception is recommended for 28 days prior to starting therapy, while participating in this study, during dose interruptions, and for at least 3 days after discontinuation of ibrutinib, 28 days after discontinuation of lenalidomide, and 12 months after discontinuation of rituximabXx_NEWLINE_xXPatients should not receive growth factors or transfusions for at least 7 days prior to first dose of study drug, with the exception of pegylated G-CSF (pegfilgrastim) and darbopoeitin which require at least 14 days prior to screening and randomizationXx_NEWLINE_xXConcurrent systemic immunosuppressant therapy other than corticosteroids (e.g., cyclosporine A, tacrolimus, etc.) within 28 days of the first dose of study drugXx_NEWLINE_xXBilirubin =< 1.5 x ULN within 14 days prior to study registration; unless patient has Gilbert’s diseaseXx_NEWLINE_xXSubject who is receiving or has received any other investigational agents within 28 days prior to day 1 of treatment in this study; in addition, day 1 of the study treatment should be at least 14 days after prior chemotherapyXx_NEWLINE_xXInclusion Criteria:\n\n        All Participants:\n\n          -  Confirmed diagnosis of multiple myeloma (MM)\n\n          -  Measurable disease\n\n          -  Archival or newly obtained bone marrow material available. In addition, for\n             participants in the United States (US) and Canada, able to provide newly obtained bone\n             marrow aspirate for biomarker analysis.\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\n          -  Adequate organ function\n\n          -  Female participants of childbearing potential must be willing to use 2 methods of\n             birth control or be surgically sterile, or abstain from heterosexual activity for the\n             course of the study through 120 days after the last dose of study treatment\n\n          -  Male participants must agree to use a latex condom during sexual contact with females\n             of childbearing potential even if they have had a successful vasectomy starting with\n             the first dose of study treatment through 120 days after the last dose of study\n             treatment\n\n          -  Able to swallow capsules and able to take or tolerate oral medications on a continuous\n             basis\n\n        Dose Determination Arm, Dose Confirmation Arm and Cohort 1 Participants:\n\n          -  Failed at least 2 lines of prior therapy (e.g. bortezomib or carfilzomib and either\n             thalidomide, pomalidomide, or lenalidomide)\n\n          -  Prior anti-MM treatments must have included an immunomodulatory (IMiD) treatment\n             (lenalidomide, pomalidomide or thalidomide) AND proteasome inhibitor (bortezomib or\n             carfilzomib) alone or in combination and participant must have failed therapy with an\n             IMiD OR proteasome inhibitor\n\n          -  Must agree to follow the regional requirements for lenalidomide counseling, pregnancy\n             testing, and birth control; willing and able to comply with the regional requirements\n             (for example, periodic pregnancy tests and safety labs)\n\n        Cohort 2 Participants:\n\n          -  MM with relapsing or refractory disease at study entry\n\n          -  Received prior treatment with 1 to 3 lines for MM\n\n          -  Achieved a partial response to at least one prior regimen (defined as ?50% decrease in\n             tumor burden)\n\n          -  Left ventricular ejection fraction of at least 40%\n\n        Exclusion Criteria:\n\n        All Participants:\n\n          -  Currently participating in and receiving study therapy or has participated in a study\n             of an investigational agent or using an investigational device within 4 weeks of the\n             first dose of study treatment\n\n          -  History of repeated infections; primary amyloidosis; hyperviscosity; plasma cell\n             leukemia; polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and\n             skin changes (POEMS) syndrome or Waldenström's macroglobulinemia\n\n          -  Diagnosis of immunosuppressive disorder or on any other immunosuppressive therapy\n             within 7 days prior to the first dose of study treatment\n\n          -  Received a prior monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who\n             has not recovered (i.e. ? Grade 1 or at baseline) from a baseline AE or a Grade 1 AE\n             associated with agents administered more than 4 weeks earlier\n\n          -  Prior anti-MM therapy (including dexamethasone), targeted small molecule therapy, or\n             radiation therapy within 2 weeks prior to study Day 1 or not recovered from AEs due to\n             a previously administered agent\n\n          -  An additional malignancy that is progressing or requires active treatment within the\n             last 5 years\n\n          -  Clinically active central nervous system (CNS) involvement\n\n          -  Active autoimmune disease or a documented history of autoimmune disease, or a syndrome\n             that requires systemic steroids or immunosuppressive agents\n\n          -  Has a history of (non-infectious) pneumonitis that required steroids or current\n             pneumonitis\n\n          -  Active infection requiring intravenous systemic therapy\n\n          -  Known psychiatric or substance abuse disorders that would interfere with cooperation\n             with the requirements of the study\n\n          -  Pregnant or breastfeeding, or expecting to conceive or father children within the\n             projected duration of the study, starting with the pre-screening or screening visit\n             through 120 days after the last dose of study treatment\n\n          -  Prior therapy with an anti-programmed cell death (PD)-1, anti-PD ligand 1\n             (anti-PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-Cytotoxic\n             T-lymphocyte-associated antigen-4 (CTLA-4) agent\n\n          -  Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C\n             Virus (HCV) infection\n\n          -  Clinically significant coagulopathy\n\n          -  Known symptomatic congestive heart failure, unstable angina pectoris, or cardiac\n             arrhythmia\n\n          -  Has had or is planning for allogeneic stem cell transplant\n\n          -  Autologous stem cell transplant within 12 weeks before the first infusion\n\n          -  History of Grade 4 rash associated with thalidomide treatment\n\n          -  Known hypersensitivity to thalidomide, lenalidomide or pomalidomide\n\n          -  Received a live vaccine within 30 days of planned start of study treatment\n\n        Dose Determination Arm, Dose Confirmation Arm and Cohort 1 Participants:\n\n          -  Known gastrointestinal disease that may significantly alter the absorption of\n             lenalidomide\n\n          -  Unable or unwilling to undergo antithrombotic prophylactic treatment\n\n        Cohort 2 Participants:\n\n          -  Smoldering MM (SMM), monoclonal gammopathy of undetermined significance (MGUS), plasma\n             cell leukemia or Waldenström's macroglobulinemia\n\n          -  Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to the\n             first dose of study treatment\n\n          -  Myocardial infarction within 4 months prior to randomization, New York Heart\n             Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of\n             severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick\n             sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3\n             conduction system abnormalities unless participant has a pacemaker.\n\n          -  Known history of allergy to CAPTISOL® (a cyclodextrin derivative used to solubilize\n             carfilzomib)\n\n          -  Hypersensitivity to carfilzomib, bortezomib, boron, or mannitol\n\n          -  Contraindication to any of the required concomitant drugs or supportive treatments,\n             including hypersensitivity to all anticoagulation and antiplatelet options, antiviral\n             drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment\n\n          -  Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to the first\n             dose of study treatment\n\n          -  Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14\n             days prior to the first dose of study treatmentXx_NEWLINE_xXTreatment with proton pump inhibitors within 3 days prior to study entryXx_NEWLINE_xXThe following laboratory results must be met within 21 days of patient registration:Xx_NEWLINE_xXThrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapyXx_NEWLINE_xXPatients must have newly diagnosed active multiple myeloma (MM); except where otherwise indicated below that assessment is required within 14 days, all tests for establishing baseline disease status must be completed within 28 days prior to registration for patients with no prior therapy, or within 28 days prior to initiation of first Induction course for patients with prior therapyXx_NEWLINE_xXFor the Phase II portion only, patients must have high-risk MM based on one or more of the following criteria at the time of initial diagnosis (prior to any chemotherapy):\r\n* Poor-risk genomic signature according to the University of Arkansas 70-gene model (available clinically as myeloma prognostic risk score [MyPRS] score, Signal Genetics, Inc) AND/OR\r\n* Translocation (14;16), and/or translocation (14;20), and/or deletion (17p) by fluorescence in-situ hybridization (FISH) or cytogenetics AND/OR\r\n* Primary plasma cell leukemia (defined by either >= 2,000 plasma cells/mL of peripheral blood, or 20% on a manual differential count) AND/OR\r\n* Serum lactate dehydrogenase (LDH) >= 2 x institutional upper limit of normal (IULN) AND/OR\r\n* 1q21 amplification by FISH analysis AND/OR\r\n* High risk by the SKY92 signature\r\n* All tests for establishing high risk status must be completed within 28 days prior to registration for patients with no prior therapy, or within 28 days prior to initiation of first Induction course for patients with prior therapyXx_NEWLINE_xXPatients must have measurable disease within 28 days prior to registration (or prior to initiation of first induction course for patients with prior therapy)Xx_NEWLINE_xXPatients must have history and physical examination within 28 days prior to registrationXx_NEWLINE_xXNo enzyme-inducing anti-epileptic drugs (EIAED) such as carbamazepine, phenytoin, phenobarbital, or primidone within 14 days before Day 1.Xx_NEWLINE_xXLast dose of therapeutic glucocorticosteroids given greater than 14 days prior to start of study treatment.Xx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of baselineXx_NEWLINE_xXDONOR: Any contraindication to the administration of subcutaneous G-CSF at a dose of 16 mg/kg/day for 5 consecutive daysXx_NEWLINE_xXPRIOR TO STEP 1 REGISTRATIONXx_NEWLINE_xXPRIOR TO STEP 2 REGISTRATIONXx_NEWLINE_xXAndrogen deprivation therapy started after prostatectomy and prior to step 1 registration for > 6 weeks (42 days)Xx_NEWLINE_xXPleurodesis within 14 days prior to first dose of study drugXx_NEWLINE_xXLymphocyte count >= 0.5 x 10^9/L, obtained within 14 days prior to initiation of study treatmentXx_NEWLINE_xXSerum bilirubin 1.5 x ULN, obtained within 14 days prior to initiation of study treatmentXx_NEWLINE_xXAppropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination within 42 +/- 5 days of planned surgical procedure (18-21 days from day 1);\r\n* Further protocol-specific assessmentsXx_NEWLINE_xXReceived other treatments for MDS within 28 days prior to first dose (example [eg], azacitidine, decitabine, lenalidomide, Erythropoiesis-Stimulating Agent (ESA) (8 weeks for long-acting ESAs)Xx_NEWLINE_xXAny anti-myeloma drug treatment within 14 days before randomization, including dexamethasone.Xx_NEWLINE_xXPatients with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ?28 days before study treatmentXx_NEWLINE_xXPatients with ECHO EF >= 45% within 28 days prior to registrationXx_NEWLINE_xXserious persistent infection within 14 days prior to the start of study medication;Xx_NEWLINE_xXInclusion Criteria:\n\n        All Subjects:\n\n          1. Provide signed and dated informed consent prior to study-specific screening procedures\n\n          2. ? 18 years old\n\n          3. Karnofsky performance status (KPS) ? 70\n\n          4. Must have adequate bone marrow and renal/hepatic function within protocol specified\n             limits\n\n          5. Disease-free period of > 2 years from any other previous malignancies, excluding\n             curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or\n             carcinoma in situ of the cervix. Subjects with prostate cancer Stage 1 that do not\n             require treatment may also be included\n\n          6. Women and men must use protocol approved methods of contraception\n\n          7. Must be able and willing to comply with the study visit schedule and study procedures\n\n          8. Must have available archived tumor tissue and willing and able to provide consent for\n             study access to such tissue\n\n             For Phase 1 Subjects Only:\n\n          9. Histologically or cytologically documented diagnosis of solid tumor for which no\n             standard therapy is recognized or have failed or intolerant to the standard-of-care\n             treatment\n\n         10. Inoperable metastatic or locally advanced, unresectable disease\n\n         11. Subjects may have either evaluable or measurable disease\n\n         12. Subjects with treated (surgically excised or irradiated) and stable brain metastases\n             are eligible as long as the subject has adequately recovered from treatment and the\n             treatment was ? 28 days prior to initiation of study drug(s) and baseline brain\n             computed tomography (CT) with contrast or magnetic resonance imaging (MRI) ? 14 days\n             of initiation of study drug is negative for new brain metastases\n\n             For Phase 2 Subjects Only:\n\n         13. Histologically confirmed diagnosis of GBM\n\n         14. Subjects must have documented recurrence after first-line treatment\n\n         15. Prior first-line treatment must have included radiation and temozolomide\n\n         16. Subject is suitable for re-resection, per Investigator discretion, as a component of\n             their clinical care\n\n         17. No more than one prior resection (Note: biopsy does not count as prior resection)\n\n        Exclusion Criteria:\n\n        All Subjects\n\n          1. Subjects who have had recent systemic anticancer therapies, interventional device\n             treatment and/or radiotherapy either within 14 days prior to first dose of study\n             drug(s) or have not recovered (to grade ? 1) from all clinically significant\n             toxicities related to prior therapies\n\n          2. Subjects who have had any major surgery (not including re-resection surgery required\n             in Phase 2) within 28 days prior to first dose of study drug(s), or minor surgery\n             within 14 days prior to first day of study drug(s)\n\n          3. Subjects taking any protocol prohibited medications within 14 days prior to initiating\n             study drug(s) treatment\n\n          4. Subjects who have been treated with an investigational agent or investigational\n             interventional device within 21 days prior to the first dose of study drug(s)\n\n          5. History of significant cardiac disease\n\n          6. Pregnant or breastfeeding\n\n          7. Any other significant co-morbid conditions that in the opinion of the Investigator\n             would impair study participation or cooperation\n\n             For Phase 1 Subjects Only:\n\n          8. Subjects with lymphoma as primary cancer\n\n             For Phase 2 Subjects Only:\n\n          9. Subjects unable or unwilling to consent to the provision of resected tissue after\n             surgeryXx_NEWLINE_xXAgree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug.Xx_NEWLINE_xXAt least 21 days since the last dose of bevacizumab, other antibody, or interferon.Xx_NEWLINE_xXHistory of any of the following within the last 6 months before administration of the first dose of study drugXx_NEWLINE_xXFor Cohort 1: has received sorafenib within 14 days of first dose of study drugXx_NEWLINE_xXhave had unprotected sexual intercourse within 30 days before study entry,Xx_NEWLINE_xXUsed any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.Xx_NEWLINE_xXClinical laboratory values within the following parameters (repeat within 3 days before the first dose of study drug if laboratory values used for randomization were obtained more than 3 days before the first dose of study drug):Xx_NEWLINE_xXTreatment with any anti leukemic/anti MDS therapies (eg, lenalidomide, cytarabine, anthracyclines, purine analogs) or with any investigational products within 14 days before the first dose of any study drug.Xx_NEWLINE_xXConcurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 20mg/day of prednisone) within 14 days of the first dose of study drugXx_NEWLINE_xXPerformance status of 0, 1 or 2 within 28 days prior to registrationXx_NEWLINE_xXAdequate thyroid function within 28 days prior to registration defined as serum thyroid-stimulating hormone (TSH) in normal rangeXx_NEWLINE_xXAdequate oxygen saturation via pulse oximeter within 28 days prior to registration (i.e., patient can NOT have CTCAE hypoxia grade 2 or greater)Xx_NEWLINE_xXMajor surgical procedures ?28 days, or minor procedures ?7 days.Xx_NEWLINE_xXExposure to other investigational products within 28 days prior to Screening VisitXx_NEWLINE_xXThe use of dietary supplements or herbal medications within 7 days of starting study therapyXx_NEWLINE_xXPatients who have received any investigational agent, chemotherapy, interferon-alpha, or 2-chlorodeoxyadenosine (2-CdA, cladribine) within 30 days prior to day 1; or monoclonal antibody =< 6 weeks prior to first administration of study treatment (patients with an AHNMD with progressive leukocytosis who require control of their counts are permitted to be given hydroxyurea); EXCEPTION: midostaurin can be used up to 10 days before the start of the study drug (study day 1)Xx_NEWLINE_xXRecent infection requiring systemic treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXUse of any vaccines against infectious diseases (e.g., influenza, varicella, etc.) within 4 weeks (28 days) of initiation of study therapy and 60 days after the last administration of the study medication.Xx_NEWLINE_xXTamoxifen therapy less than 14 days before first dose of study treatmentXx_NEWLINE_xXPart A, B and C: Fulvestrant therapy less than 90 days before first dose of study treatment. Part D: Fulvestrant therapy less than 42 days before first dose of study treatmentXx_NEWLINE_xXAny other anti-cancer endocrine therapy less than 14 days before first dose of study treatmentXx_NEWLINE_xXAny chemotherapy less than 28 days before first dose of studyXx_NEWLINE_xXPrior cell therapy for relapse within the past 90 daysXx_NEWLINE_xXAn interval of >= 4 weeks after the last administration of any investigational agent or prior cytotoxic therapy (except bevacizumab); there should be 14 days interval between the last dose of bevacizumab and first day of treatment on studyXx_NEWLINE_xXHistory/physical examination within 7 days prior to registrationXx_NEWLINE_xXEvidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 7 days prior to registrationXx_NEWLINE_xXPatient has received other investigational drugs with 14 days before enrollmentXx_NEWLINE_xXKnown active brain metastasis unless they have been treated and shown documented radiographic stability for 28 daysXx_NEWLINE_xXHave received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectivelyXx_NEWLINE_xXMajor injuries within the past 10 days prior to start of study treatment with incomplete wound healingXx_NEWLINE_xXEvaluation by a medical oncologist within 45 days prior to study registrationXx_NEWLINE_xXHistory/physical examination within 45 days prior to study registrationXx_NEWLINE_xXBrain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 90 days prior to Step 1 Initial Registration; eligible patients should be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to Step 1 Initial RegistrationXx_NEWLINE_xXPatients must have a complete physical examination and medical history within 28 days prior to Step 2 RandomizationXx_NEWLINE_xXSerum creatinine =< 1.5 x IULN within 14 days prior to Step 2 Randomization ORXx_NEWLINE_xXPatients must have an electrocardiogram (ECG) within 14 days prior to Step 2 RandomizationXx_NEWLINE_xXAST and ALT =< 2.5 x IULN or =< 5 x IULN if liver metastases are present within 14 days prior to Step 3 registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x IULN within 14 days prior to Step 3 registrationXx_NEWLINE_xXSerum creatinine =< 1.5 x IULN within 14 days prior to Step 3 registration ORXx_NEWLINE_xXHave discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug.Xx_NEWLINE_xXHave received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.Xx_NEWLINE_xXTreatment with any investigational drug within 28 days prior to randomizationXx_NEWLINE_xXPrior EGFR inhibitor within 6 days; received prior treatment with any other agent with antitumor activity chemotherapy, radiotherapy, or immunotherapy within 14 days; any investigational therapy within 28 days or 5 half-lives, whichever is shorter; blood transfusion or hemopoietic factor within 14 days; major surgery within 14 days; any strong CYP3A4 inhibitors within 7 daysXx_NEWLINE_xXEvidence of nonhealing wounds, ulcers, or bone fractures within 28 days prior to study entry.Xx_NEWLINE_xXInvestigation or cytotoxic therapy within 28 days or nitrosoureas within 42 days of the first treatment with G-202Xx_NEWLINE_xXCurrently receiving or has received any intensive chemotherapy within the 14 days prior to the first dose of study drug (day -7) (Hydrea or other non-intensive regimens such as decitabine may be used but must stop at least one day prior to the first dose of study drug)Xx_NEWLINE_xXPresence of uncontrolled seizures =< 5 days prior first drug dose, defined as status epilepticus or multiple seizures not responding to appropriate therapyXx_NEWLINE_xXInsufficient time for recovery from prior therapy:\r\n* Less than 28 days from WBRT or SRS;\r\n* Less than 28 days from any investigational agent, \r\n* Less than 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine, irinotecan or topotecan administration), and \r\n* Less than 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. \r\n* When radiation necrosis is suspected, standard of care (SOC) confirmatory imaging, such as MRI perfusion, magnetic resonance (MR) spectroscopy and or positron emission tomography (PET) will be performed, and patients with findings consistent with radiation necrosis will be excludedXx_NEWLINE_xXShould be off any active systemic therapy for AML with the exception of hydroxyurea for at least 14 days prior to study registration unless patient has rapidly progressive disease, and all grade 2-4 non-hematologic toxicities should have resolvedXx_NEWLINE_xXRadiotherapy within 14 days before first dose of study drug; if the involved field is small, 7 days will be considered a sufficient interval between treatment and study initiationXx_NEWLINE_xXNo experimental medications within 30 days of study entryXx_NEWLINE_xXAcceptable laboratory assessment obtained within 14 days prior to the first dose of study drug:Xx_NEWLINE_xXSplenic irradiation within 3 months prior to the first dose of study drugXx_NEWLINE_xXSystemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 6 months.Xx_NEWLINE_xXPatients who have received any investigational agent, chemotherapy, interferon-alfa, or 2-chlorodeoxyadenosine (2-CdA, cladribine) within 30 days prior to day 1Xx_NEWLINE_xXUse of erectile dysfunction drugs (e.g., Cialis, Viagra) within 14 days prior to treatment or during studyXx_NEWLINE_xXAt least 14 days must have elapsed since completion of myelosuppressive therapyXx_NEWLINE_xXAt least 7 days must have elapsed since the completion of therapy with a non-myelosuppressive biologic agent or retinoidXx_NEWLINE_xXGastric or esophageal varices that require interventional treatment within 28 days prior to randomization. Prophylaxis with pharmacologic therapy (eg, nonselective beta-blocker) is permitted.Xx_NEWLINE_xXMeasurable or evaluable disease, as defined in 2008 Revised Response Criteria for Malignant Lymphoma; baseline scans used for measurement should be obtained within 30 days of registration, and baseline bone marrow biopsy and/or aspiration should be obtained with 90 days of registrationXx_NEWLINE_xXThe subject has received radiation therapy:\r\n* To the thoracic cavity or gastrointestinal tract within 3 months before the first dose of study treatment\r\n* To brain metastasis within 14 days before the first dose of study treatment\r\n* To any other site(s), with the exception of bone, within 28 days before the first dose of study treatmentXx_NEWLINE_xXSurgically rendered free of disease within 90 days of randomizationXx_NEWLINE_xXPSA blood test within 60 days prior to registrationXx_NEWLINE_xXProstate biopsy within 180 days prior to registrationXx_NEWLINE_xXParticipation in another research study involving an investigational agent within 30 days prior to consent or projected study participation during the 28 days post study randomization.Xx_NEWLINE_xXUse of biologic response modifiers within 60 days of first dosingXx_NEWLINE_xXReceived alemtuzumab or other anti-Tcell antibody within 28 daysXx_NEWLINE_xXWomen must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from protocol treatmentXx_NEWLINE_xXMales must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from protocol treatmentXx_NEWLINE_xXPatients participating in an investigational new drug protocol within 14 days before enrollmentXx_NEWLINE_xXSubject has experienced acute pathologic fracture or spinal cord compression within 28 days prior to first dose of study therapyXx_NEWLINE_xXPatients must have sufficient time for recovery from prior therapy: 28 days from any investigational agent, 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration), and 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc.Xx_NEWLINE_xXMust have completed definitive resection of primary tumor. The last surgery for breast cancer must have been completed at least 14 days prior to registration for protocol therapy.Xx_NEWLINE_xXAppropriate stage for protocol entry, based upon the following minimum diagnostic workup within 60 days prior to registration:\r\n* History/physical examination including weight, performance data, body surface areaXx_NEWLINE_xXBaseline serum PSA value performed with an Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration\r\n* Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT; (3) within 30 days after discontinuation of finasteride; or (4) within 90 days after discontinuation of dutasterideXx_NEWLINE_xXUse of finasteride within 30 days prior to registrationXx_NEWLINE_xXUse of dutasteride within 90 days prior to registrationXx_NEWLINE_xXWillingness to maintain a low iodine diet for 12 days (starting 7 days prior to virus injection continuing until after the I131 radioiodine therapy on Day 5)Xx_NEWLINE_xXUse of any known CYP2C8 substrates with a narrow therapeutic window is not allowed during the study and patients must come off 14 days prior to receiving the first dose of AMG 232Xx_NEWLINE_xXCriteria for Inclusion:\n\n          1. Female patient ? 18 years\n\n          2. Willing and able to give informed consent\n\n          3. Stage III-IV platinum-sensitive (defined as a lack of progression by RECIST v1.1\n             criteria following completion of standard-of-care chemotherapy, including a minimum of\n             4 cycles of a platinum-containing regimen) epithelial ovarian, fallopian tube or\n             primary peritoneal carcinoma in first remission.\n\n          4. Histologic documentation of diagnosis of carcinoma is required and the following\n             histologic subtypes are eligible: high grade (grade ?3+) serous or endometrioid\n             carcinoma, carcinosarcoma, or poorly-differentiated adenocarcinoma, or mixed\n             (including above subtypes only). Note that synchronous serous or endometrioid uterine\n             or fallopian cancers are allowed.\n\n          5. The patient must have demonstrated an objective response (PR or CR) or stable disease\n             (SD) with the last chemotherapy prior to enrollment and this response must be stable\n             (without progressive disease) before randomization.\n\n          6. Patients must receive their first dose of vaccine within 1 year of completion of their\n             final dose of a chemotherapeutic agent of the platinum-containing regimen\n\n          7. Adequate normal organ and marrow function within 14 days prior to first vaccine\n             administration:\n\n               -  Absolute neutrophil count > 1.5 x 109/L\n\n               -  Platelet > 100 x 109/L\n\n               -  Hemoglobin > 9.0 g/dL\n\n               -  Serum bilirubin < 1.5 times ULN (unless Gilbert's syndrome without concurrent\n                  clinically significant liver disease\n\n               -  AST/ALT < 2.5 ULN unless liver metastasis in which case it must be < 5 x ULN\n\n               -  Serum creatinine CL > 40 mL/min by Cockcroft-Gault formula.\n\n          8. Anti-nuclear antibody (ANA) negative or low-positive institutional range, as\n             determined within 28 days from registration. Intermediate values (usually defined by a\n             titer of ?1:80, or as indicated by institutional range) are acceptable if there are,\n             in the opinion of the Investigator, no early signs of an autoimmune disease.\n\n          9. Female subjects must either be of non-reproductive potential (i.e. post-menopause by\n             history: > 60 years old and no menses for > 12 months naturally or secondary to\n             radiation/chemotherapy; OR serum FSH, LH and estradiol levels in the post-menopausal\n             range; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history\n             of bilateral oophorectomy), or must have a negative serum pregnancy test upon study\n             entry\n\n         10. Life expectancy > 24 weeks\n\n         11. ECOG performance status of 0 or 1\n\n         12. Formalin fixed, paraffin embedded tumor sample from the primary cancer must be sent\n             for central testing.\n\n        Criteria for Exclusion\n\n          1. Histology consistent with non-serous, non-endometrioid (i.e. mucinous or clear cell),\n             or low-grade or borderline serous ovarian carcinoma\n\n          2. Patients with a history of other cancers (other than non-melanoma skin cancers [i.e.\n             basal or squamous cell]) within the past 3 years.\n\n          3. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, targeted\n             therapy, biological/cell therapy, tumor embolization, monoclonal antibodies, other\n             investigational agent) < 28 days prior to the first dose of study drug.\n\n          4. Current or prior use of immunosuppressive medication within 28 days prior to the fist\n             dose of study drug with the exception of topical, intranasal or inhaled\n             corticosteroids or systemic corticosteroids at physiological doses, which are not to\n             exceed 10 mg/day of prednisone, or an equivalent corticosteroid.\n\n          5. Active autoimmune disease requiring therapy within the past 2 years. Note: patients\n             with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within\n             the past 2 years are not excluded.\n\n          6. History of hypersensitivity to GM-CSF\n\n          7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active\n             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable\n             angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active\n             bleeding diatheses including any subject known to have evidence of acute or chronic\n             hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric\n             illness/social situations that would limit compliance with study requirements or\n             compromise the ability of the subject to give written informed consent\n\n          8. Symptomatic thyroid disease, unless negative for thyroid antibodies (TSH receptor,\n             TPO, thyroglobulin).\n\n          9. Subjects who are pregnant or are breast feeding.\n\n         10. Subjects who or of reproductive potential, and are either:\n\n               -  Not abstinent;\n\n               -  Not in an exclusive relationship with a partner who is surgically sterile;\n\n               -  Not employing an effective method of birth control.\n\n         11. Any condition that, in the opinion of the investigator, would interfere with\n             evaluation of study treatment or interpretation of patient safety or study results\n\n         12. Symptomatic or uncontrolled brain metastasis requiring concurrent treatment, inclusive\n             of but not limited to surgery, radiation and/or corticosteroids\n\n         13. Subject with uncontrolled seizuresXx_NEWLINE_xXHormone replacement therapies (estrogens, megestrol acetate) within 14 days prior to day 1 of protocol therapyXx_NEWLINE_xXThe patient has received treatment with chemotherapy, external-beam radiation, or other systemic anticancer therapy within 14 days prior to study therapy administration (42 days for prior nitrosourea or mitomycin-C; patients with advanced prostate cancer who are receiving LHRH agonists are permitted onto the study and should continue use of these agents during study treatment).Xx_NEWLINE_xXReceived systemic anti-cancer therapy within 30 days of Week 0, Day 11 of study treatment.Xx_NEWLINE_xXPatient needing valproic acid during the study or within 5 days prior to first doseXx_NEWLINE_xXNeed for transfusion within 14 days prior to the first dose of trial treatmentXx_NEWLINE_xXAgree not to try to become pregnant during the study and for 180 days after the final study drug administrationXx_NEWLINE_xXFemale subject must agree not to breastfeed starting at screening and throughout the study period, and for 60 days after the final study drug administration.Xx_NEWLINE_xXFemale subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.Xx_NEWLINE_xXMale subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.Xx_NEWLINE_xXHydroxyurea for ? 14 daysXx_NEWLINE_xXHave an expected survival of > 60 daysXx_NEWLINE_xXDonor lymphocyte infusion (DLI) within 28 days prior to enrollmentXx_NEWLINE_xXPrior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first BTCT4465A (Mosunetuzumab) administrationXx_NEWLINE_xXPatients must have baseline laboratory tests within the following parameters within 14 days prior to registration:Xx_NEWLINE_xXSystemic treatment with corticosteriods or other immunosuppressive medications within 14 days of study drug administrationXx_NEWLINE_xXThe first dose of atezolizumab in the crossover arm should be within 42 days of last dose but no less than 21 days from the last dose prior to crossing overXx_NEWLINE_xXReceived any subsequent anti-cancer therapies from the time between the last dose of atezolizumab prior to the first administration of study drug after crossing overXx_NEWLINE_xXWhole brain radiation within 28 days or other radiotherapy within 14 days prior to first administration of study drug after crossing overXx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 28 days before start of treatment.Xx_NEWLINE_xXInclusion Criteria:\n\n        Prior to vaccine production -\n\n          1. Diagnosis of advanced cancer (solid tumor) that:\n\n               1. May be receiving or about to start another line of therapy.\n\n               2. If on a line of therapy or about to start a new line of therapy, it is\n                  anticipated that the treatment may provide short-term tumor control.\n\n          2. Available tissue from an archival tissue sample or tissue from a biopsy done during\n             the initial screen, or both. If archival tissue is not available or tissue is not\n             mainly tumor, subjects must be willing to undergo a biopsy or surgery to remove some\n             or all of their tumor for next generation sequencing. New tissue should be obtained\n             prior to starting a new line of therapy, if applicable.\n\n          3. Minimum estimated life expectancy of 6 months.\n\n          4. Age 18 years or older.\n\n          5. Signed written informed consent to allow transfer of tumor tissue and production of\n             vaccine.\n\n          6. Discussion about each patient should occur with the Medical Monitor to confirm\n             eligibility.\n\n        Prior to Treatment -\n\n        Patients who had vaccine manufactured but were treated with an additional line of treatment\n        may start vaccine if they continue to meet the remaining eligibility criteria.:\n\n          1. Diagnosis of advanced cancer (solid tumor) that is refractory to standard therapies.\n\n          2. Signed written informed consent for treatment.\n\n          3. Minimum estimated life expectancy of 3 months.\n\n          4. Eastern Cooperative Oncology Group (ECOG) performance status <2.\n\n          5. Adequate bone marrow function (absolute neutrophil count [ANC] ?1,500/mm^3; absolute\n             lymphocyte count [ALC] ?500/mm^3; platelet count 100,000/mm^3), adequate liver\n             function (serum glutamic oxaloacetic transaminase [SGOT]/aspartate aminotransferase\n             [AST] and alkaline phosphatase <2.5 times the institutional upper limit of normal\n             [IULN], total bilirubin <1.5 mg/dL), and adequate renal function (creatinine <1.5 x\n             IULN).\n\n          6. Adequate cardiac function (New York Heart Association [NYHA] class ?II).\n\n          7. All participants (males and females) must agree to use adequate contraception\n             (hormonal or barrier method of birth control, abstinence) prior to study treatment and\n             for the duration of study participation.\n\n        Female subjects of childbearing potential should have a negative serum pregnancy test at\n        pre-treatment visit and within 72 hours prior to receiving the first dose of study\n        medication.\n\n        Female subjects of childbearing potential must agree to use 2 methods of birth control or\n        be surgically sterile, or abstain from heterosexual activity prior to receiving the first\n        dose of study medication through 30 days after the last dose of study medication.\n\n        Exclusion Criteria:\n\n        Subjects must not meet any of the following exclusion criteria at the time of tumor\n        procurement. All exclusion criteria must be confirmed prior to treatment.\n\n          1. Diagnosis of immunodeficiency or actively receiving systemic steroid therapy or any\n             other form of immunosuppressive therapy within 7 days prior to the first dose of trial\n             treatment.\n\n          2. Corticosteroid dependency.\n\n          3. Requirement for immunosuppressive medication aside from corticosteroids.\n\n          4. Active or history of any autoimmune disease (subjects with diabetes type 1, vitiligo,\n             psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment\n             are eligible) or immunodeficiencies.\n\n          5. History of treated or untreated brain metastases or leptomeningeal spread of disease.\n\n          6. History or current evidence of any condition, therapy, or laboratory abnormality that\n             might confound the results of the trial, interfere with the subject's participation\n             for the full duration of the trial, or is not in the best interest of the subject to\n             participate, in the opinion of the treating investigator.\n\n          7. Known medical, psychiatric or substance abuse disorders that would preclude\n             participation in the study.\n\n          8. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active\n             infection, interstitial lung disease or active, non-infectious pneumonitis,\n             symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or\n             psychiatric illness/social situations that would limit compliance with study\n             requirements.\n\n          9. Known to be positive for human immunodeficiency virus (HIV). Testing is not required\n             in the absence of history or high index of suspicion.\n\n         10. Intolerance of prior immunotherapy treatment necessitating cessation of therapy.\n\n         11. History of intolerance or allergic reactions attributed to compounds of similar\n             chemical or biologic composition to AutoSynVax™ vaccine or QS-21.\n\n         12. Women who are pregnant or breastfeeding.\n\n         13. Inability to comply with protocol.\n\n        Prior to Treatment - Subjects must not meet any of the following exclusion criteria prior\n        to treatment in addition to the other exclusion criteria listed above.\n\n          1. Receipt of anticancer medications or investigational drugs within the following\n             intervals before first administration of study drug:\n\n               1. ?14 days for chemotherapy, targeted small molecule therapy, anticancer hormone\n                  therapy or radiation therapy. Subjects must also not have had radiation\n                  pneumonitis as a result of treatment, and cannot participate in the study if they\n                  are on chronic corticosteroids for radiation pneumonitis or other reasons. A\n                  1-week washout is permitted for palliative radiation to non-CNS disease with\n                  sponsor approval.\n\n               2. Note: Bisphosphonates and denosumab are permitted medications. Novel imaging\n                  agents that have Phase 1 safety data and have not demonstrated therapeutic\n                  activity are also permitted.\n\n               3. ?28 days for a prior immunotherapy.\n\n               4. ?28 days for prior monoclonal antibody used for anticancer therapy with the\n                  exception of denosumab.\n\n               5. ?7 days for immunosuppressive-based treatment for any reason. Systemic\n                  corticosteroids are not allowed.\n\n                  Note: Use of inhaled or topical corticosteroid use for radiographic procedures is\n                  permitted.\n\n                  Note: Patients receiving physiologic steroid replacement for adrenal\n                  insufficiency are eligible (i.e. < 10 mg prednisone per day).\n\n                  Note: The use of physiologic corticosteroid replacement therapy may be approved\n                  after consultation with the sponsor.\n\n               6. ?28 days before the first dose for all other investigational study drugs or\n                  devices.\n\n          2. Receipt of other investigational agents or other anticancer therapies during treatment\n             with AutoSynVax™ vaccine.\n\n          3. Receipt of a live vaccine within 30 days prior to the first dose of trial treatment.Xx_NEWLINE_xXReceived no other investigational therapy within the past 14 daysXx_NEWLINE_xXPlatelets (PLT) >= 50,000/uL; platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment, obtained =< 21 days prior to registration and confirmed prior to the first dose of study drugXx_NEWLINE_xXCurrent or recent (=< 10 days prior to randomization) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes, unless the patient has been on a stable dose of anticoagulants for at least 2 weeks at the time of randomization; Note: the use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or activated partial thromboplastin time (aPTT) is within therapeutic limits (according to the medical standard of the institution) and the patient has been on a stable dose of anticoagulants >= 14 days at the time of randomization; prophylactic use of anticoagulants is allowedXx_NEWLINE_xXCurrent or recent (=< 90 days prior to randomization) endoluminal stent in the stomach, bowel, colon or rectumXx_NEWLINE_xXColonoscopy, sigmoidoscopy, or proctoscopy =< 7 days prior to randomizationXx_NEWLINE_xXCurrent or recent (=< 28 days prior to randomization) use of sorivudine, brivudine, and St. John’s wortXx_NEWLINE_xXParticipants who have had < 28 days since the last chemotherapy, immunotherapy, biological therapy, or < 14 days from approved tyrosine kinase inhibitor (TKI) therapy (sunitinib, sorafenib, vemurafenib, dabrafenib, cobretinib), or systemic or inhaled steroid therapy at doses greater than 10mg of prednisone or equivalent before administration of the first dose of study medication.Xx_NEWLINE_xXOpen wounds or unhealed fractures within 28 days of starting study treatmentXx_NEWLINE_xXHave received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.Xx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXReceipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) before the first planned dose of study drugsXx_NEWLINE_xXInclusion Criteria: (All Subjects)\n\n          -  Male or female adult subjects ?18 years of age\n\n          -  Diagnosis of histologically or cytologically confirmed for:\n\n               -  For Schedule 1 and 2: advanced solid tumor malignancy that is refractory to\n                  standard therapy and/or for whom no further standard therapy is available\n\n               -  For Schedule 3: advanced/metastatic tumors for which mFOLFOX6 is appropriate, or\n                  advanced/metastatic tumors that may be sensitive to each component of mFOLFOX6 or\n                  sensitive to topoisomerase 1 inhibitors including pancreatic, colorectal,\n                  esophageal, gastric, bladder or ovarian cancer, triple-negative breast cancer,\n                  small cell lung cancer (SCLC), cholangiocarcinoma, among others\n\n          -  For Schedules 1 and 2: Eastern Cooperative Oncology Group (ECOG) Performance Status of\n             0 to 2, For Schedule 3: ECOG Performance Status of 0 or 1\n\n          -  Life expectancy >12 weeks in the opinion of the Investigator\n\n          -  Subjects with acceptable pre-study* hematology and biochemistry labs ?3 days prior to\n             Week 1 Day 1 (W1D1) defined as:\n\n               -  absolute neutrophil count (ANC) ?1.500 cells / µL (1.5 x 10°/L, without growth\n                  factor support\n\n               -  platelet count ?100,000 cells/µL (100 x 10° cells/L), without growth factor\n                  support\n\n               -  hemoglobin ?9 g/dL (90/g/L)\n\n               -  serum total bilirubin ?1.5 upper limit of normal (ULN), unless Gilbert's disease\n\n               -  alanine transaminase (ALT) or aspartate transaminase (AST) ?2.5 x ULN, (5 x ULN\n                  for subjects with liver metastases)\n\n               -  calculated or measured creatinine clearance ?40 mL/min\n\n                    -  NOTE: If screening hematology and biochemistry labs are performed ?3 days\n                       prior to W1D1, additional pre-study labs do not need to be repeated to\n                       confirm eligibility. However, if screening hematology and biochemistry labs\n                       are performed greater than 3 days prior to W1D1, additional pre-study labs\n                       will need to be performed to confirm continued eligibility to ensure labs\n                       remain acceptable per protocol\n\n          -  Females of childbearing potential must agree to use two effective methods of\n             contraception (or abstain completely from heterosexual intercourse) from the time of\n             informed consent and for 30 days following last dose of study drug\n\n               -  NOTE: Females of childbearing potential are defined as women physically capable\n                  of becoming pregnant unless the female subject cannot have children due to\n                  surgery or other medical reasons (effective tubal ligation, ovaries or the uterus\n                  removed, or are post-menopausal). Fertile males of childbearing potential are\n                  defined as men who are sexually capable to impregnate the female partner even if\n                  surgically sterilized (i.e., vasectomy).\n\n                    -  highly effective methods of contraception include intra-uterine device (IUD)\n                       and hormonal contraception (oral, injectable, patches or implant)\n\n                    -  effective methods of contraception include barrier methods (latex condom,\n                       diaphragm with spermicide, cervical cap, sponge)\n\n                    -  when possible, subjects should be strongly encouraged to include at least\n                       one highly effective method of contraception\n\n          -  Male subjects must agree to use appropriate method of barrier contraception (latex\n             condom with a spermicidal agent) or abstain completely from heterosexual intercourse\n             fro the time of informed consent and for 120 days following last dose of study drug\n             unless female partner absolutely cannot have children because of surgery or for other\n             medical reasons\n\n          -  Negative urine pregnancy test\n\n          -  Ability to understand and willingness to sign a written informed consent form\n\n          -  Able to comply with study visit schedule and assessments\n\n        Exclusion Criteria: (All Subjects)\n\n          -  Subject has received:\n\n               -  chemotherapy or small molecular targeted therapy <2 weeks prior to W1D1\n\n               -  approved antibody therapy <5 half-lives from W1D1 (or 4 weeks since last therapy,\n                  whichever is the shortest)\n\n               -  local palliative radiation <14 days from W1D1\n\n               -  invasive surgery requiring general anesthesia <30 days from W1D1\n\n               -  chemotherapy with nitrosoureas or mitomycin C <45 days from W1D1\n\n          -  Uncontrolled grade 2 or greater toxicity except alopecia related to any prior\n             treatment (i.e., chemotherapy, targeted therapy, radiation or surgery) within 7 days\n             prior to W1D1 unless approved by the Medical Monitor\n\n          -  Prolongation of QT/QTc interval (QTc interval >470) using the Fredericia method of QTc\n             analysis\n\n          -  Women who are pregnant or nursing\n\n          -  Any known human immunodeficiency virus (HIV) infection or acquired immune deficiency\n             syndrome (AIDS) or any concurrent infection requiring IV antibiotics\n\n          -  Any known clinically significant or concurrent acute liver disease, including viral\n             hepatitis\n\n          -  Primary brain malignant tumors\n\n          -  Subjects with uncontrolled symptomatic central nervous system (CNS) involvement\n\n          -  Subjects requiring steroids at stable dose (>4 mg/day dexamethasone or equivalent) for\n             at least 2 weeks\n\n          -  Uncontrolled hypertension >150/100 mmHg\n\n          -  Concurrent participation in any other investigational therapeutic study, unless\n             non-interventional study and approved by Sponsor\n\n          -  History of stroke, deep venous thrombosis (DVT), transient ischemic attack (TIA),\n             unstable angina, or myocardial infarction within 3 months prior to W1D1\n\n          -  Uncontrolled concurrent disease or illness including but not limited to:\n\n               -  symptomatic congestive heart failure (NYHA Class III or IV) per the NYHA\n                  Classification, unstable angina pectoris, clinically significant cardiac\n                  arrhythmia\n\n               -  unstable or untreated cardiac conditions or ejection fraction of <50% as\n                  determined by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)\n\n               -  diabetes mellitus (i.e., fasting blood glucose >220 despite acceptable chronic\n                  diabetes therapy)\n\n               -  psychiatric illness that would limit compliance with study requirements, as\n                  determined by the Investigator\n\n          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory\n             abnormality that may increase the risk associated with study participation or study\n             drug administration or that may interfere with the interpretation of study results\n             and, in the judgment of the Investigator, would make the subject inappropriate for the\n             study.\n\n          -  Known hypersensitivity to any component of CRLX101 or excipient or documented medical\n             condition that would prohibit adequate pre-medication with antihistamine.\n\n          -  Presence of ?Grade 1 cystitis\n\n        Exclusion Criteria for Subjects Enrolled in Schedule 2 Only\n\n          -  Minor surgical procedure, excluding placement of a vascular access device, within 24\n             hours prior to W1D1.\n\n          -  Cardiovascular disease defined as congestive heart failure (NYHA Class II, III, or IV)\n             per the NYHA Classification, angina pectoris requiring nitrate therapy, or myocardial\n             infarction within the last 6 months prior to therapy\n\n          -  Uncontrolled hypertension (defined as the presence of systolic blood pressure ?150\n             mmHg or diastolic blood pressure ?100 mmHg on two separate occasions. Blood pressure\n             must be controlled to a systolic blood pressure <150 mmHg and/or to diastolic blood\n             pressure <100 mmHg prior to study treatment), or any prior history of hypertensive\n             crisis or hypertensive encephalopathy\n\n          -  Peripheral vascular disease >Grade 1\n\n          -  Known congenital long QT syndrome, history of torsades de pointes or ventricular\n             tachycardia.\n\n          -  Known history of pulmonary hypertension or non-infectious interstitial pneumonitis.\n\n          -  History or evidence of thrombotic or hemorrhagic disorders: including cerebrovascular\n             accident (CVA) / stroke or transient ischemic attack (TIA), intracerebral hemorrhage\n             or sub- arachnoid hemorrhage ? 6 months prior to W1D1\n\n          -  Chronic daily aspirin >325 mg/day or clopidogrel (>75 mg/day)\n\n          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess\n             within 6 months prior to randomization\n\n          -  Any of the following serious, non-healing conditions:wound, ulcer, or bone fracture\n\n          -  Proteinuria at screening as demonstrated by either: urine dipstick ?2+ (subjects\n             discovered to have a ?2+ proteinuria on dipstick urinalysis at baseline should undergo\n             24-hour urine collection and must demonstrate <1g of protein in 24 hours to be\n             eligible): 24-hour urine collection demonstrates >1g of protein in 24 hours\n\n          -  Immunocompromised subjects, including known seropositivity for human immunodeficiency\n             virus (HIV), or current or chronic hepatitis B and/or hepatitis C infection (as\n             detected by positive testing for hepatitis B surface antigen [HbsAg] or antibody to\n             hepatitis C virus [anti HCV] with confirmatory testing). [Note: testing is not\n             mandatory to be eligible for the study. However, if a subject is at risk for having\n             undiagnosed hepatitis C virus (HCV) (due to history of injection drug use or due to\n             geographic location for example), testing at screening should be considered]\n\n          -  Chronic treatment with corticosteroids (prednisone >12.5 mg/day or dexamethasone >2\n             mg/day excluding inhaled steroids\n\n        Exclusion Criteria for Subjects Enrolled in Schedule 3 Only\n\n          -  Known hypersensitivity to 5FU, oxaliplatin or other platinum agent, or to their\n             excipients\n\n          -  Known dihydropyridine dehydrogenase (DPD) enzyme deficiency (testing not required)\n\n          -  Baseline peripheral neuropathy grade ? 2\n\n          -  Progressive disease within ? 6 months of completing an oxaliplatin containing adjuvant\n             therapy\n\n          -  Interstitial lung disease with ongoing signs and symptoms at the time of informed\n             consentXx_NEWLINE_xXObtained =< 7 days prior to registration:\r\nCreatinine =< 2 x ULNXx_NEWLINE_xXRecent prior therapy, defined as follows: 1) Any investigational or Food and Drug Administration (FDA)-approved anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of GSK2820151. Any nitrosoureas or mitomycin C within 42 days prior to the first dose of GSK2820151. Prior therapy with monoclonal antibodies is permitted so long as 14 days have elapsed since therapy and all therapy-related toxicity has resolved to Grade 1 or less. Note that an investigational drug is defined as a drug without an approved oncologic indication. 2) Any radiotherapy within 14 days or major surgery within 28 days prior to the first dose of GSK2820151. 3) Anti-androgen therapies for prostate cancer, such as bicalutamide, must be stopped 4 weeks prior to enrollment. Second-line hormone therapies such as enzalutamide, abiraterone, or orteronel should be stopped 2 weeks prior to enrolment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone (up to 10 milligrams [mg]/day) and still be eligible for this study. 4) In addition, any therapy-related toxicity must have resolved to Grade 1 or less, with the exception of alopecia (acceptable at any Grade) and peripheral neuropathy (which must be Grade 2 or less prior to enrollment).Xx_NEWLINE_xXHemoptysis >1 teaspoon in 24 hours within the last 28 days.Xx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days of first doseXx_NEWLINE_xXPatient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.Xx_NEWLINE_xXSubject has used any of the following within 28 days before the Day 1 visit:Xx_NEWLINE_xXTreatment with non-Food and Drug Administration (FDA) approved drug within 21 days of start of this trialXx_NEWLINE_xXSubjects who have been on hormonal therapy up to 30 days prior to enrollment and receiving degarelix are allowed to be on the studyXx_NEWLINE_xXPrevious treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapyXx_NEWLINE_xXAny non-study related significant surgical procedures within the past 28 days prior to the first administration of study drugXx_NEWLINE_xXSubject has received other investigational drugs within 14 days prior to first dose of study drug.Xx_NEWLINE_xXAdequate hematologic, organ, and coagulation within 2 weeks (14 days) prior to randomization.Xx_NEWLINE_xXAdministration of live vaccines =< 14 days prior to registration; note: patients may not receive any viral immunizations during the study and for 28 days after the last dose of ReolysinXx_NEWLINE_xXThe participant is receiving chronic therapy with any of the following within 7 days prior to randomization:Xx_NEWLINE_xXAll necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrollmentXx_NEWLINE_xXSubjects must not donate blood while on study and for at least 90 days following the last MEDI4736 treatment.Xx_NEWLINE_xXThe subject has received radiation therapy:\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatmentXx_NEWLINE_xXAll baseline laboratory requirements will be assessed and should be obtained within -14 days of study registrationXx_NEWLINE_xXPatients who received aspirin or metformin within the past 28 daysXx_NEWLINE_xXBacterial peritonitis within 30 daysXx_NEWLINE_xXPatients must have received their last dose of known myelosuppressive anticancer therapy greater than 28 days prior to study enrollment or > 42 days if nitrosoureaXx_NEWLINE_xXPatients must have received their last dose of any other investigational agent greater than 28 days prior to enrollment (with exception of fluorothymidine F-18 [FLT])\r\n* Patients must have received their last dose of any other biologic agent greater than 7 days prior to enrollmentXx_NEWLINE_xXPatients must have received their last dose of any other biologic agent greater than 7 days prior to enrollment\r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur and discussed with the PIXx_NEWLINE_xXPatients on alternative supplements should strongly be encouraged to discontinue them prior to enrollment; if they opt to continue, they may enroll on study as long as they have been receiving the supplement for at least 30 days, there is NO evidence of hepatic, renal or other organ dysfunction, administration is approved by the PI, and administration is documented in the study diaryXx_NEWLINE_xXPatients should have no significant worsening in clinical status for a minimum of 2 days prior to enrollmentXx_NEWLINE_xXImmunotherapy within the 21 days prior to randomizationXx_NEWLINE_xXFocal therapy within the 7 days prior to randomizationXx_NEWLINE_xXExtended field therapy within the 21 days prior to randomizationXx_NEWLINE_xXAny major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to study registration, and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to registrationXx_NEWLINE_xXTreatment with surgery or chemotherapy within 21 days prior to study entry or radiation within 14 days of study entry.Xx_NEWLINE_xXInvestigational drug use within 28 days of randomization.Xx_NEWLINE_xXPatients who have completed sipuleucel-T (Provenge ®) treatment within 30 days of study entry.Xx_NEWLINE_xXAdequate coagulation functioning within 28 days prior to registration for protocol therapy defined by either of the following criteria:Xx_NEWLINE_xXMust have stable disease or disease response as evidenced on CT evaluation a minimum of 28 days and a maximum of 56 days following the completion of chemoradiationXx_NEWLINE_xXThe subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone)Xx_NEWLINE_xXThe subject has received any of the following prior anticancer therapy:\r\n* Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT); Note: stereotactic radiosurgery (SRS) is allowed\r\n* Non-bevacizumab systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study drug\r\n* Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug, with the exception of bevacizumab which can be 14 days or maintain the subject's current bevacizumab dosing schedule\r\n* Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug\r\n* Prior treatment with carmustine wafers\r\n* Prior treatment with TH-302Xx_NEWLINE_xXPost-transplant exposure to any novel immunosuppressive medication (e.g., alemtuzumab) within 100 days prior to enrollmentXx_NEWLINE_xXInclusion Criteria - Cohort 1:\n\n          -  Received and progressed on ?2 prior chemotherapy regimens for their advanced disease;\n             prior regimen must have included a cisplatin and a fluoropyridine\n\n          -  Human epidermal growth factor receptor 2 (HER-2/neu) negative, or, if HER2/neu\n             positive, must have previously received treatment with trastuzumab\n\n        Inclusion Criteria - Cohort 2 or 3:\n\n          -  HER2/neu negative\n\n          -  Has not received prior systemic anti-cancer therapy for their advanced carcinoma\n             (systemic therapy received in the neoadjuvant and adjuvant setting does not count)\n\n        Inclusion Criteria - All Participants:\n\n          -  Histologically- or cytologically-confirmed recurrent or metastatic gastric or\n             gastroesophageal junction adenocarcinoma that is considered incurable by local\n             therapies\n\n          -  Willing to provide tissue for PD-L1 biomarker analysis from newly-obtained and/or\n             archival tissue\n\n          -  Measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1\n             (RECIST 1.1)\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days\n             prior to first dose of study drug\n\n          -  Life expectancy of >=3 months\n\n          -  Female participants of childbearing potential should have a negative pregnancy test\n             and be willing to use 2 methods of birth control or be surgically sterile, or abstain\n             from heterosexual activity for the course of the study through 120 days after the last\n             dose of study drug (180 days for participants receiving cisplatin + 5FU)\n\n          -  Male participants should agree to use an adequate method of contraception starting\n             with the first dose through 120 days after the last dose of study drug (180 days for\n             participants receiving cisplatin + 5FU)\n\n          -  Adequate organ function\n\n        Exclusion Criteria - All Participants:\n\n          -  Currently participating and receiving study therapy or participated in a study of an\n             investigational agent and received study therapy or used an investigation device\n             within 4 weeks of the first dose of study drug\n\n          -  Active autoimmune disease that has required systemic treatment in past 2 years\n\n          -  Immunodeficiency or receiving systemic steroid therapy or any other form of\n             immunosuppressive therapy within 7 days prior to the first dose of study drug\n\n          -  Weight loss >10% over 2 months prior to first dose of study drug\n\n          -  Clinical evidence of ascites by physical exam\n\n          -  Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not\n             recovered from AEs due to agents administered more than 4 weeks earlier\n\n          -  Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2\n             weeks prior to study Day 1 or who has not recovered from AEs due to a previously\n             administered agent\n\n          -  Known additional malignancy that is progressing or requires active treatment excepting\n             basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has\n             undergone potentially curative therapy or in situ cervical cancer\n\n          -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis\n\n          -  Known history of, or any evidence of active, non-infectious pneumonitis\n\n          -  Active infection requiring systemic therapy\n\n          -  Psychiatric or substance abuse disorders that would interfere with cooperation with\n             the requirements of the study\n\n          -  Pregnant or breastfeeding, or expecting to conceive or father children within the\n             projected duration of the study, starting with the screening visit through 120 days\n             after the last dose of study drug (180 days for participants receiving cisplatin +\n             5FU)\n\n          -  Prior therapy with an anti-programmed death-1 (PD-1), anti-PD-L1, or anti-PD-L2 agent\n\n          -  Human immunodeficiency virus (HIV)\n\n          -  Hepatitis B or C\n\n          -  Received live vaccine within 30 days of planned start of study drugXx_NEWLINE_xXSubjects who are currently taking or have received hormones (eg, estrogen or progesterone) within 7 days the first dose of study drug. Note: Luteinizing hormone-releasing hormone (LHRH) analogs are permissible.Xx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days before the first dose of their assigned Investigational Product;Xx_NEWLINE_xXAppropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination within 28 days prior to registrationXx_NEWLINE_xXPatients may not have the following co-morbid disease or concurrent illness:\r\n* Chronic or acute gastrointestinal (GI) disorders resulting in diarrhea of any severity grade; patients may not use chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to first dose of investigational drug (exception: anti-diarrheal medications used to control symptoms from a medication that will be discontinued prior to study are allowed with a 7 day washout before study therapy, for example loperamide for erlotinib-associated diarrhea)\r\n* Known cirrhosis, defined as Child Pugh class A or higher liver disease\r\n* Other malignancy undergoing active treatment\r\n* Any other severe/uncontrolled inter-current illness or significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperationXx_NEWLINE_xXAnti-cancer therapy =< 14 days prior to randomizationXx_NEWLINE_xXGroup C: progression following ceritinib is required and the last dose of ceritinib must be no more than 60 days prior to the first dose of study drug.Xx_NEWLINE_xXMale subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 180 days after the last dose of study drug.Xx_NEWLINE_xXWillingness to abstain from all omega-3 fish oil supplements for 30 days prior to baseline evaluation and during the study interventionXx_NEWLINE_xXEnrollment within 28 days of the date of radiographic diagnosisXx_NEWLINE_xXBlood urea nitrogen (BUN) =< 30 mg/dl within 21 days prior to study registrationXx_NEWLINE_xXAny investigation agents must be discontinued at least 30 days prior to study treatment initiationXx_NEWLINE_xXUse of any standard/experimental anti-lymphoma drug therapy, including steroids, within 3 weeks of initiation of the study or use of any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of initiation of the study drug treatmentXx_NEWLINE_xXAnticipated blood donation within the next 90 daysXx_NEWLINE_xXEnrollment in other studies for any disease in the past 30 daysXx_NEWLINE_xXHave used any systemic steroids within 14 days of study treatmentXx_NEWLINE_xXInclusion Criteria\n\n        a. History of morphologically confirmed AML w/ classification other than WHO Acute\n        Promyelocytic Leukemia (FAB M3), based on bone marrow examination.\n\n        i. not a candidate for allogeneic HSCT or no intention to move to HSCT at time of\n        enrollment.\n\n        ii. Patient's AML could be in morphologic CR or no further cytotoxic chemotherapy is\n        currently being considered.\n\n        iii. Completed consolidation chemotherapy, if available and/or appropriate for patient.\n\n        iv. Can have history of allogeneic HSCT transplant, but must be off immunosuppression for\n        at least 2 wks. before enrollment and w/o GVHD and/or toxicities from HSCT.\n\n        b. Diagnosed in past 5 years w/ smoldering MM at high risk of progressing to symptomatic\n        MM.\n\n        i. Diagnosis defined as: Bone marrow infiltration with plasma cells (PCs) ?10% and presence\n        of a monoclonal component, Ig G ?3 g/dl or IgA ?2 g/dl or Bence-Jones proteinuria >1 g/dl\n        and absence of lytic lesions on skeletal survey, absence of hypercalcemia (corrected\n        calcium <11 mg/dl), absence of renal failure (creatinine ?1.5 x ULN), and absence of anemia\n        (hemoglobin >10 g/dl or not 2 g/dl below LLN).\n\n        ii. Must meet one of following:\n\n          -  ?10% PCs in bone marrow and IgG ?3 g/dl or IgA ?2 g/dl,\n\n          -  ?10% PCs in bone marrow and serum FLC ratio (involved : uninvolved) >100 in blood, or\n\n          -  IgG ?3 g/dl or IgA ?2 g/dl and FLC ratio (involved: uninvolved) >100 in blood. c. MM\n             post-treatment disease that is clinically stable and does not require treatment at\n             least 4 weeks prior to enrollment.\n\n             i. At least one line of treatment and achieved at least PR by IMWG ii. Stable disease\n             or better per IMWG based on 2 subsequent assessments at least one month apart d.\n             history of morphologically confirmed MDS i. previously received at least one treatment\n             for MDS, including but not limited to chemotherapy or hypomethylating agent(s).\n             Subjects may be previously untreated if they refuse treatment with or are not\n             appropriate candidates for chemotherapy or hypomethylating agent(s) in the\n             investigator's opinion.\n\n        ii. intermediate, high, or very high risk MDS by IPSS-r iii. No curative intent option of\n        allogeneic HSCT or refused consideration for allogeneic HSCT iv. Could have history of\n        allogeneic HSCT transplant and relapsed, but must be off immunosuppression for at least 2\n        weeks before enrollment and without GVHD and/or toxicities from HSCT.\n\n        2. Low, moderate, to high levels of OFA expression by IHC analysis of tumor specimens.\n\n        3. HLA-A*02 haplotype.\n\n        4. ECOG performance status 0 to 2.\n\n        5. 18 years or older.\n\n        6. life expectancy ?3 months.\n\n        7. Has following laboratory parameters w/in 28 days:\n\n          -  ANC ?500/mm3\n\n          -  ALC >500/mm3\n\n          -  PLT ?25,000/mm3 and may be transfused\n\n          -  Hgb >8 g/dL (may have been transfused)\n\n          -  Serum creatinine ?1.5 x ULN\n\n          -  Total bilirubin ?2.0 mg/dL, unless elevated bilirubin due to Gilbert's syndrome\n\n          -  ALT and AST less than 5×ULN\n\n             8. If female of child-bearing potential, negative serum pregnancy test result w/in 28\n             of D1 and agree to abstain from heterosexual intercourse or use acceptable method of\n             birth control (hormonal or barrier method) from Screening through 30 days after last\n             dose\n\n             9. If male having sexual contact with a female of child-bearing potential, agrees to\n             use a latex condom dor agrees to ensure partner uses an acceptable method of birth\n             control (hormonal or barrier method)from Screening through 30 days after last dose\n\n             10. Able to provide written informed consent\n\n        Exclusion Criteria\n\n          1. Received chemotherapy, biological therapy, or radiation therapy less than one month\n             before D1\n\n          2. No prior history of active CNS involvement\n\n          3. Grade 2 or higher peripheral neuropathy w/in 28 days\n\n          4. Acute promyelocytic leukemia (FAB M3)\n\n          5. Other active systemic malignancy treated w/ cytotoxic chemotherapy in previous 12 mos.\n\n          6. Monoclonal gammopathy of undetermined significance\n\n          7. For smoldering MM, baseline bone lesions or plasmacytomas\n\n          8. For smoldering MM, lytic lesions on skeletal surveys and hypercalcemia (i.e., ?11\n             mg/dL)\n\n          9. Known HIV or hepatitis virus infection\n\n         10. Active infection requiring antibiotics\n\n         11. History of prior or active autoimmune disease such as Lupus or rheumatoid arthritis\n\n         12. Significant kidney or liver disease, uncontrolled severe cardiovascular or pulmonary\n             disease, other uncontrolled medical condition that would compromise subject's ability\n             to tolerate study treatment\n\n         13. Received any investigational treatment w/in 30 days\n\n         14. Receiving systemic glucocorticosteroid >10 mg daily. Concurrent use after registration\n             on study should be restricted to equivalent of prednisone 10 mg per day. Prior or\n             concurrent topical or localized glucocorticosteroid therapy to treat non-malignant\n             comorbid disorders is permitted. Subject requiring routine use of steroid inhalers are\n             not eligible.\n\n         15. Major surgery w/in 4 wks.\n\n         16. G-CSF w/in 30 daysXx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI6383. )Xx_NEWLINE_xXAny of the following prior therapies:\r\n* Chemotherapy =< 21 days prior to registration\r\n* Mitomycin C/nitrosoureas =< 42 days prior to registration\r\n* Immunotherapy =< 28 days prior to registration\r\n* Biologic therapy =< 28 days prior to registration\r\n* Radiation therapy =< 21 days prior to registration\r\n* Radiation to > 25% of bone marrow prior to registration\r\n* Hormonal therapy =< 14 days prior to registrationXx_NEWLINE_xXPlans to begin bisphosphonates or denosumab after registration or began therapy regiment =< 30 days from registration\r\n* NOTE: patients on a stable dose of bisphosphonates or denosumab > 30 days prior to registration are acceptableXx_NEWLINE_xXSubjects must be neurologically stable for at least 14 days prior to first dose of study drug;Xx_NEWLINE_xXPatients who have required a blood transfusion within 28 days prior to study startXx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days before the first dose of MEDI4736Xx_NEWLINE_xXTreatment with any investigational products within 14 days before the first dose of study drug and systemic anticancer therapy within 28 days before the first dose of study drug.Xx_NEWLINE_xXSystemic corticosteroid (inhalers are allowed) within 7 days before the first dose of study drug.Xx_NEWLINE_xXParticipant has had plasmapheresis within 28 days of randomizationXx_NEWLINE_xXStarted screening no earlier than 75 days after transplant, completed screening within 15 days, and randomized no later than 115 days after transplant.Xx_NEWLINE_xXHematologic function, as follows (no platelet transfusion within 2 weeks and no RBC transfusion within 4 days before the first dose of study drug)Xx_NEWLINE_xXUse of any investigational drug (including marketed drugs not approved for this indication) within 14 days prior to the first dose of study drugXx_NEWLINE_xXPlatelet transfusion within 2 weeks and RBC transfusion within 4 days before the first dose of study drugXx_NEWLINE_xXSubjects receiving systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc.) within 28 days of the first dose of study drug are not eligibleXx_NEWLINE_xXAnti-cancer therapy (including immunotherapy) =< 4 weeks prior to registration/randomization; exception: adjuvant Leukine =< 14 days prior to registration/randomizationXx_NEWLINE_xXFine needle aspirations or core biopsies =< 7 days prior to registration/ randomizationXx_NEWLINE_xXActive or recent history of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) =< 30 days prior to registration/randomizationXx_NEWLINE_xXSystemic therapeutic radionuclide delivery within 30 days prior to treatmentXx_NEWLINE_xXUse of other investigational drugs within 28 days preceding the first dose of vemurafenib during this studyXx_NEWLINE_xXAny of the following prior therapies:\r\n* Cytotoxic chemotherapy =< 14 days prior to registration\r\n* Immunotherapy =< 14 days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< 14 days prior to registration\r\n* Radiation therapy =< 14 days prior to registration\r\n* Targeted therapies (i.e. kinase inhibitors, =< 7 days or 5 half-life’s whichever is shorter)\r\n* Patients must be off other biologic therapies including hematopoietic growth factors >= 7 days prior to registration\r\n* For steroids or other non-cytotoxics given for blast count control, patient must be off for > 24 hours (hrs) before starting therapy; NOTE: hydroxyurea (HU) is allowed for blast count control throughout study\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 14 days prior to registrationXx_NEWLINE_xXWide field radiotherapy (including therapeutic radioisotopes such as strontium-89) administered ?28 days or limited field radiation for palliation ?7 days prior to starting study drug or has not recovered from side effects of such therapyXx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708Xx_NEWLINE_xXPatients will be registered on study based on the local exam under anesthesia (EUA) done for diagnostic purposes prior to study entry; the EUA done at study entry should be done within 14 days prior to study entryXx_NEWLINE_xXHave a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonistXx_NEWLINE_xXHave received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectivelyXx_NEWLINE_xXHave received recent (within 28 days prior to randomization) yellow fever vaccinationXx_NEWLINE_xXAcceptable laboratory assessments obtained within 14 days prior to RandomizationXx_NEWLINE_xXSubjects must be off any steroids 7 days prior to the initiation of treatmentXx_NEWLINE_xXSubjects must be off any curcumin, tumeric, or vitamin D supplements for 14 days prior to the initiation of treatmentXx_NEWLINE_xXBiologic (anti-neoplastic agent): at least 14 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur; these subjects must be discussed with the study chair on a case-by-case basisXx_NEWLINE_xXPatients with hemoptysis within 28 days prior to entering the studyXx_NEWLINE_xXUse of an investigational treatment from 30 days prior to the first dose of SNX-5422 and during the study.Xx_NEWLINE_xXReceived any other therapeutic investigational agent within 30 days of screening, except for immunotherapy. Patients with previous immunotherapy are not eligible regardless of timing.Xx_NEWLINE_xXPatient must not be on any other systemic immunosuppressant therapy other than corticosteroids within 28 days of the first dose of study drugXx_NEWLINE_xXOther clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within 28 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatmentXx_NEWLINE_xXReceiving concurrent androgens, anti-androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to enrollment or having taken finasteride or dutasteride within 30 days of registrationXx_NEWLINE_xXNo increase in steroid dose within the past 7 daysXx_NEWLINE_xXPatients on steroids for symptom management must be on a stable dose for 7 days prior to start of treatmentXx_NEWLINE_xXParticipants must have had their last dose of cytotoxic chemotherapy at least 28 days prior to enrollment, their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 7 days prior to enrollment, their last dose of a monoclonal antibody at least 30 days prior to enrollment, and their last dose of any investigational agent at least 30 days prior to enrollmentXx_NEWLINE_xXParticipants receiving a medication that has a known risk of QTc prolongation or is associated with torsades de pointes or any prohibited medications, concomitantly or within 14 days (28 days for levomethadyl) of enrollmentXx_NEWLINE_xXThe patient has received maintenance dose chemotherapy (e.g., low dose cyclophosphamide) ? 7 days from the first dose of Investigational Product.Xx_NEWLINE_xXPatients who received ? 14 days of letrozole or anastrozole for advanced disease prior to randomization are eligible.Xx_NEWLINE_xXActive infection =< 5 days prior to registration or fever > 38 degrees Celsius (C) on day of registrationXx_NEWLINE_xXPlatelets >= 100 x 10^9/L (tested within 14 days prior to registration)\r\n* Subjects may not have had a transfusion within 7 days of screening assessmentXx_NEWLINE_xXFOCBP must have a negative pregnancy test within 7 days prior to registration on study\r\n* Note: female patients who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drugXx_NEWLINE_xXAdministration of any non-oncologic investigational drug within 28 days prior to receiving the first dose of therapyXx_NEWLINE_xXPositive culture for or other clinical evidence of infection with bacteria or fungus within 14 days of the initiation of study treatmentXx_NEWLINE_xXmust agree not to try to become pregnant during the study and for 180 days after the final study drug administration, andXx_NEWLINE_xXFemale subject must not be breastfeeding at Screening or during the study period, and for 60 days after the final study drug administration.Xx_NEWLINE_xXFemale subject must not donate ova starting at Screening and throughout the study period, and for 180 days after the final study drug administration.Xx_NEWLINE_xXMale subject must not donate sperm starting at Screening and throughout the study period and for 120 days after the final study drug administration.Xx_NEWLINE_xXPresence of brain metastases (except for subjects in the WHO Grade 1 or 2 or 3 or 4 glioma histology cohorts) that are symptomatic or untreated or not stable for >=3 months (must be documented by imaging) or requiring corticosteroids. Subjects on a stable dose of corticosteroids >14 days and have not required treatment with enzyme-inducing anticonvulsants for >30 days prior to enrollment can be enrolled with approval of the Medical MonitorXx_NEWLINE_xXPresence of symptomatic or untreated leptomeningeal or spinal cord compression. Subjects who have been previously treated for these conditions and have stable CNS disease (documented by consecutive imaging studies) for >60 days, are asymptomatic and currently not taking corticosteroids, or have been on a stable dose of corticosteroids for at least 30 days prior to enrollment, are permittedXx_NEWLINE_xXPatients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.Xx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must satisfy the following criteria to be enrolled in the study:\n\n          1. Subject is ? 18 years of age at the time of signing the informed consent form (ICF).\n\n          2. Subject must understand and voluntarily sign an ICF prior to any study-related\n             assessments/procedures being conducted.\n\n          3. Subject is willing and able to adhere to the study visit schedule and other protocol\n             requirements.\n\n          4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.\n\n          5. Subjects must have a documented diagnosis of MM and measurable disease at enrollment.\n\n          6. Subjects must have the following laboratory values:\n\n               -  Absolute neutrophil count (ANC) ? 1.25 x 109/L without growth factor support for\n                  ? 7 days (? 14 days for pegfilgrastim).\n\n               -  Hemoglobin (Hgb) ? 8 g/dL.\n\n               -  Platelets (plt) ? 75 x 109/L without transfusion for ? 7 days (? 50 x 109/L for\n                  subjects with > 50% plasma cells in bone marrow).\n\n               -  Corrected serum calcium ? 13.5 mg/dL (? 3.4 mmol/L).\n\n               -  24-hr creatinine clearance (CrCl) ? 45 mL/min.\n\n               -  AST/SGOT and ALT/SGPT ? 3.0 x upper limit of normal (ULN).\n\n               -  Serum bilirubin ? 1.5 x ULN.\n\n               -  Uric acid ? 7.5 mg/dL (446 ?mol/L).\n\n               -  PT/INR < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN, (for\n                  subjects not receiving therapeutic anticoagulation).\n\n          7. Females of childbearing potential (FCBP) must:\n\n               1. Have two negative pregnancy tests as verified by the Investigator prior to\n                  starting study therapy. She must agree to ongoing pregnancy testing during the\n                  course of the study, and after discontinuation of CC-92480. This applies even if\n                  the subject practices true abstinence* from heterosexual contact.\n\n               2. Either commit to true abstinence* from heterosexual contact (which must be\n                  reviewed on a monthly basis and source documented) or agree to use, and be able\n                  to comply with, two reliable forms of contraception without interruption, 28 days\n                  prior to starting CC-92480, during the study therapy (including during dose\n                  interruptions), and for 28 days after discontinuation of study therapy.\n\n          8. Male subjects must:\n\n               1. Practice true abstinence* (which must be reviewed on a monthly basis) or agree to\n                  use of a condom during sexual contact with a pregnant female or a female of\n                  childbearing potential while participating in the study (even during dose\n                  interruptions) and for at least 3 months following CC-92480 discontinuation, even\n                  if he has undergone a successful vasectomy.\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment:\n\n          1. Subject has a significant medical condition, laboratory abnormality, or psychiatric\n             illness that would prevent the subject from participating in the study.\n\n          2. Subject has any condition including the presence of laboratory abnormalities, which\n             places the subject at unacceptable risk if he/she were to participate in the study.\n\n          3. Subject has any condition that confounds the ability to interpret data from the study.\n\n          4. Subject has non- or oligosecretory multiple myeloma.\n\n          5. Subject has plasma cell leukemia or active leptomeningeal myelomatosis.\n\n          6. Subject has documented, systemic light chain amyloidosis or Polyneuropathy,\n             Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS)\n             Syndrome.\n\n          7. Subject has immunoglobulin class M (IgM) myeloma.\n\n          8. Subject has a history of allogeneic bone marrow transplantation.\n\n          9. Subject is undergoing dialysis.\n\n         10. Subjects with peripheral neuropathy ? Grade 2.\n\n         11. Subjects with gastrointestinal disease that may significantly alter the absorption of\n             CC-92480.\n\n         12. Subject has impaired cardiac function or clinically significant cardiac disease,\n             including any of the following:\n\n               -  LVEF < 45% as determined by ECHO or MUGA scan at Screening.\n\n               -  Complete left bundle branch, bifascicular block or other clinically significant\n                  abnormal electrocardiographic (ECG) finding at Screening.\n\n               -  A prolongation of QT interval on Screening ECG; a history of or current risk\n                  factors for Torsades de Pointe; and concurrent administration of medications that\n                  prolong the QT/QTc interval.\n\n               -  Congestive heart failure (New York Heart Association Class III or IV).\n\n               -  Myocardial infarction ?6 months prior to starting CC-92480.\n\n               -  Unstable or poorly controlled angina pectoris, including the Prinzmetal variant\n                  of angina pectoris.\n\n         13. Concurrent administration of strong CYP3A modulators.\n\n         14. Subject had prior systemic myeloma treatment (approved or investigational) ? 5\n             half-lives or 4 weeks prior to starting CC-92480, whichever is shorter.\n\n         15. Subject had major surgery ? 2 weeks prior to starting CC-92480.\n\n         16. Subject is a pregnant or nursing female or intends to become pregnant during\n             participation in the study.\n\n         17. Subject has known human immunodeficiency virus (HIV) infection.\n\n         18. Subject has known active chronic hepatitis B or C virus (HBV/HCV) infection.\n\n         19. Subject has a history of concurrent second cancer requiring ongoing systemic\n             treatment.\n\n         20. Subjects has a history of prior malignancy other than MM, unless the subject has been\n             free of disease for ?3 years except for the following noninvasive malignancies treated\n             with curative intent:\n\n         21. Subject has known or suspected hypersensitivity to the excipients contained in the\n             formulation of CC-92480 or dexamethasone.\n\n         22. Subject has undergone either of the following within 14 days of initiating CC-92480:\n\n               -  Plasmapheresis.\n\n               -  Radiation therapy other than local therapy for symptomatic relief of MM\n                  associated bone lesions.\n\n         23. Subject has received immunosuppressive medication within 14 days prior to the first\n             dose of CC-92480.Xx_NEWLINE_xXAnti-CD20 monoclonal antibodies within 7 days prior to leukapheresisXx_NEWLINE_xXVenetoclax within 4 days prior to leukapheresisXx_NEWLINE_xXIdelalisib within 2 days prior to leukapheresisXx_NEWLINE_xXTreatment with systemic therapy for the primary disease within 14 days (except for hydroxyurea or isolated doses of cytarabine or decitabine for white blood cell control)Xx_NEWLINE_xXAnti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil counts): ?7 days after the last dose of agentXx_NEWLINE_xXCorticosteroids: If used to modify immune adverse events related to prior therapy, ?14 days must have elapsed since last dose of corticosteroid. Participants receiving corticosteroids, who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment, are not eligibleXx_NEWLINE_xXRadiotherapy (XRT)/External Beam Irradiation including Protons: ?14 days after local XRT; ?150 days after total body irradiation, craniospinal XRT or if radiation to ?50% of the pelvis; ?42 days if other substantial bone marrow radiation.Xx_NEWLINE_xXCentral line placement or subcutaneous port placement is not considered major surgery. External central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment.Xx_NEWLINE_xXFine needle aspirate within 7 days prior to enrollment.Xx_NEWLINE_xXThrombotic/ thromboembolic event requiring systemic anticoagulation within 90 days prior to enrollmentXx_NEWLINE_xXConcurrent systemic immunosuppressant therapy other than corticosteroids (e.g. cyclosporine A, tacrolimus, etc) within 28 days of the first dose of study drugXx_NEWLINE_xXPrior use of investigational drugs =< 14 days prior to registrationXx_NEWLINE_xXImmunotherapy within 28 days prior to signing consentXx_NEWLINE_xXReceiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatmentXx_NEWLINE_xXREGISTRATIONXx_NEWLINE_xXAt the time of registration; patients must have recovered from the toxic effects of prior therapy:\r\n* >= 28 days from any investigational agent\r\n* >= 28 days from prior cytotoxic therapy\r\n* >= 14 days from vincristine\r\n* >= 42 days from nitrosoureas\r\n* >= 21 days from procarbazine administration\r\n* > 21 days from bevacizumab administration and\r\n* >= 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count); any questions related to the definition of non-cytotoxic agents should be directed to the Academic principal investigator (PI)Xx_NEWLINE_xXPatients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:\r\n* They have recovered from the effects of surgery and be > 28 days from surgery\r\n* Residual disease following resection of recurrent GBM or GS is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to registration; if the 96-hour scan is more than 14 days before registration, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 daysXx_NEWLINE_xXPrior use of 5-alpha reductase inhibitors is permitted provided such medications were stopped 7-14 days prior to enrollmentXx_NEWLINE_xXPatient has received other investigational drugs with 14 days before enrollmentXx_NEWLINE_xXPatient has received other investigational drugs with 14 days before enrollmentXx_NEWLINE_xXPatients must be at least 28 days post immunosuppressants prior to enrollmentXx_NEWLINE_xXPatients must be at least 28 days from use of any mushroom supplements (examples: turkey tail, reishi, maitake, shiitake) and agree to withhold them for the entire study period (one year)Xx_NEWLINE_xXSubjects who received systemic anticancer therapy or radiotherapy <14 days prior to their first day of study drug administration. (Hydroxyurea is allowed for up to 28 days after the start of AG-221 for the control of peripheral leukemic blasts in subjects with white blood cell [WBC] counts >30,000/?L as well as prior to enrollment).Xx_NEWLINE_xXLaboratory tests required for eligibility must be completed within 7 days prior study entry; baseline tumor measurements and ECHO or MUGA must be documented from tests completed within 28 days of study entry; other non-laboratory tests must be performed within 21 days of study entryXx_NEWLINE_xXAny number of the following prior therapies is allowed:\r\n* Chemotherapy >= 28 days prior to registration\r\n* Mitomycin C/nitrosoureas >= 42 days prior to registration\r\n* Immunotherapy >= 28 days prior to registration\r\n* Biologic therapy >= 28 days prior to registration\r\n* Radiation therapy >= 28 days prior to registration\r\n* Radiation to < 25% of bone marrowXx_NEWLINE_xXPatients with active biliary obstruction; NOTE: patients for which a shunt has been in place for at least 10 days prior to the first dose of dabrafenib are allowedXx_NEWLINE_xXUse of an investigational anti-cancer drug within 28 days preceding the first dose of dabrafenibXx_NEWLINE_xXReceipt of any other investigational agents within 14 days prior to study enrollmentXx_NEWLINE_xXPatients must have a complete physical examination and medical history within 28 days prior to registrationXx_NEWLINE_xXPatients with melanoma must have a serum lactate dehydrogenase (LDH) test performed within 28 days prior to registrationXx_NEWLINE_xXHave received systemic corticosteroid (inhalers are allowed) within 7 days before the first administration of study drugXx_NEWLINE_xXPatients with the following within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist prior to entry into the studyXx_NEWLINE_xXPatients must not have experienced a core biopsy or other minor surgical procedure within 7 days prior to registration; NOTE: this excludes placement of a vascular access device up to 2 days prior to registrationXx_NEWLINE_xXPatients must be on a stable or decreased dose of steroids for at least 5 days prior to baseline imagingXx_NEWLINE_xXPatients may have not received treatment for 28 days before the first day of the study protocol (dose escalation only)Xx_NEWLINE_xXChemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment; immunotherapy, radiotherapy or experimental therapy within 28 days of first day of study drug dosing, or within six weeks of first day of study drug dosing in the event that nitrosoureas or mitomycin were used; concurrent systemic immunosuppressant therapy other than corticosteroids (e.g. cyclosporine A, tacrolimus, etc) must be discontinued within 28 days of the first dose of study drugXx_NEWLINE_xXConcurrent use of any vitamin, herb, or mineral supplements for at least 14 days prior to start of therapyXx_NEWLINE_xXPatients with chronic or acute gastrointestinal (GI) disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to study entryXx_NEWLINE_xXReceipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) before the first planned dose of study drugs; (immune checkpoint inhibitors that are antibody-based will only require 28 days before enrollment)Xx_NEWLINE_xXCurrent use of megestrol acetate (Use within 10 days of Day 1)Xx_NEWLINE_xXTreatment with an immunotherapy within 30 daysXx_NEWLINE_xXSubjects may not have had a transfusion within 7 days of screening assessmentXx_NEWLINE_xXTreatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entryXx_NEWLINE_xXObtained =< 7 days prior to registration: Potassium WNLXx_NEWLINE_xXObtained =< 7 days prior to registration: Phosphorus WNLXx_NEWLINE_xXA diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days (preferably 14 days) prior to C1D1.Xx_NEWLINE_xXInvestigational drug use within 28 days of the first dose of PLX3397 or concurrently.Xx_NEWLINE_xXPrior therapy with strontium-89, samarium, rhenium-186 etidronate, chemotherapy or androgen biosynthesis inhibitors for prostate cancer is not allowed. Previous immunologic, homeopathic, natural, or alternative medicine therapies are acceptable provided treatment ended greater than 28 days prior to initiation of study drugXx_NEWLINE_xXConcomitant use of herbal medications (i.e. St. John’s wort, Kava, ephedra [ma huang], gingko biloba) at least 7 days prior to the first dose of study drug and throughout participation in the trialXx_NEWLINE_xXAnti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI503Xx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n* At least 14 days after the last dose of myelosuppressive chemotherapy (28 days if prior nitrosourea); Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of therapy\r\n* At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* At least 3 half-lives of the antibody after the last dose of a monoclonal antibody\r\n* At least 14 days after local palliative radiation therapy (XRT) (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Patients with prior autologous or allogeneic stem cell transplant (SCT) are excluded from this study\r\n* At least 28 days must have elapsed since the most recent dose of bleomycin, to allow adequate time to detect evidence of bleomycin-related pulmonary toxicityXx_NEWLINE_xXAnti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI608.Xx_NEWLINE_xXMajor surgery within 30 days prior to start of study drug; for patients who had port-a-cath placement, they should have the port-a-cath placement at least one week prior the initiation of leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX)Xx_NEWLINE_xXTolerability of prior treatment with sorafenib defined as not less than 20 days at a minimum daily dose of 400 mg QD within the last 28 days prior to withdrawal.Xx_NEWLINE_xXPatients who have had chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C), radiotherapy within 14 days, biological therapy within 14 days, hormonal therapy within 7 days, and investigational therapy within 21 days prior to enrollmentXx_NEWLINE_xXPatients with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to enrollmentXx_NEWLINE_xXTreatment with any anti-cancer investigational drug within 28 days prior to commencing study treatmentXx_NEWLINE_xXUse of anticoagulants that cannot be discontinued both 5 days before and 5 days after EUSXx_NEWLINE_xXInclusion Criteria: Subjects eligible for enrolment in this study must meet all of the\n        following criteria\n\n          -  Provided written informed consent,\n\n          -  Male or female >=18 years of age and able to swallow and retain orally administered\n             study treatment and does not have any clinically significant gastrointestinal (GI)\n             abnormalities that may alter absorption such as malabsorption syndrome or major\n             resection of the stomach and/or bowels.\n\n          -  Part 1 and Part 2: Histologically- or cytologically-confirmed diagnosis of advanced or\n             metastatic BRAF V600E mutation positive CRC\n\n          -  Part 4A and 4B ONLY: Histologically- or cytologically-confirmed diagnosis of advanced\n             or metastatic CRC that either harbours the BRAF V600E -mutation, as determined by\n             relevant genetic testing OR has developed secondary resistance to anti-EGFR therapy,\n             defined as patients that derived benefit (disease control based on investigator\n             assessment for >6 months OR partial response [confirmed or unconfirmed] based on\n             RECIST 1.1) from prior anti-EGFR-containing therapy (as defined below) and then\n             subsequently progressed on therapy. The anti-EGFR therapy must have been the most\n             recent therapy and the patient must have progressed based on investigator assessment\n             within 3 months of screening. Acceptable prior anti-EGFR-containing therapies include:\n             a. Monotherapy anti-EGFR, including cetuximab or panitumumab OR b.\n             irinotecan/anti-EGFR combo after previously having disease progression (based on\n             investigator assessment) on an irinotecan-containing regimen\n\n          -  Part 3: Histologically- or cytologically-confirmed diagnosis of BRAFV600E mutation\n             positive advanced or metastatic colorectal cancer (CRC who are eligible to receive\n             fluoropyrimidine-containing chemotherapy regimen that have experienced documented\n             radiographic progression on one prior line of fluoropyrimidine-containing chemotherapy\n             (previous anti-EGFR therapy is excluded), Second-line for advanced/metastatic disease,\n             having failed or been intolerant to at least one regimen of\n             fluoropyrimidine-containing chemotherapy including irinotecan or oxaliplatin in the\n             advanced/metastatic setting. Enrollment in Part 3 may only occur following\n             confirmation of KRAS wild-type cancer.\n\n          -  Archival tissue is required; if archival tissue is not available or found to not\n             contain tumor tissue, a fresh biopsy is required.\n\n          -  Measurable disease per RECIST version 1.1.\n\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\n          -  Men with a female partner of childbearing potential must have either had a prior\n             vasectomy or agree to use one of the contraception methods listed in protocol.\n\n          -  Female subjects are eligible if: Non-childbearing potential defined as pre-menopausal\n             females with a documented tubal ligation or hysterectomy; or post-menopausal female\n             defined as 12 months of spontaneous amenorrhea to be verified with a\n             follicle-stimulating hormone (FSH) level >40 Milli-international units per milliliter\n             (MIU/mL) and estradiol level <40 picogram per milliliter (pg/mL). Child-bearing\n             potential and agrees to use one of the contraceptive methods listed in protocol.\n\n          -  Female subjects must agree to use contraception from 7 days prior to the first dose of\n             study drug(s) until 6 months after the last dose of panitumumab, until 4 months after\n             the last dose of trametinib, or 4 weeks after the last dose of dabrafenib, whichever\n             is longer. Additionally, women of childbearing potential must have had a negative\n             serum pregnancy test within 7 days prior to the first dose of study drug(s).\n\n          -  Adequate organ system function as defined in absolute neutrophil count greater than or\n             equal to 1.2X10^9/Liter (L), hemoglobin greater than or equal to 9 grams per deciliter\n             (g/dL) or 5.6 millimoles per litre (mmol/L), platelets greater than or equal to 75 ×\n             10^9/L, Prothrombin Time / International Normalized Ratio (PT/INR) and Partial\n             Thromboplastin Time (PTT) less than or equal to 1.5X upper limit of normal (ULN);\n             serum magnesium greater than or equal to the lower limit of normal (LLN); albumin\n             greater than or equal to 2.5 g/dL or 25 grams per liter (g/L), total bilirubin less\n             than or equal to 1.5XULN, and Aspartate aminotransferase (AST) and Alanine\n             aminotransferase (ALT) less than or equal to 2.5X ULN; creatinine less than or equal\n             to 1.5XULN or calculated creatinine clearance greater than or equal to 50mL/min; left\n             ventricular ejection fraction (LVEF) greater than or equal to the LLN by\n             echocardiography (ECHO) or multigated acquisition scan (MUGA).\n\n          -  Subjects enrolled in France or Italy: In France or Italy, a subject will be eligible\n             for inclusion in this study only if either affiliated to, or a beneficiary of, a\n             social security category.\n\n        Exclusion Criteria: Subjects meeting any of the following criteria must not be enrolled in\n        the study\n\n          -  History of prior malignancy, other than colorectal cancer.\n\n          -  Any serious and/or unstable pre-existing medical, psychiatric disorder or other\n             conditions that could interfere with subject's safety, obtaining informed consent or\n             compliance to the study procedures.\n\n          -  Current active liver or biliary disease (with the exception of Gilbert's syndrome or\n             asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease\n             per investigator's assessment).\n\n          -  History of sensitivity to heparin or heparin-induced thrombocytopenia.\n\n          -  Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy or\n             biologic therapy).\n\n          -  Prior exposure to a MEK inhibitor.\n\n          -  Part 1, Part 2 and BRAF-mutant patients in Part 4 ONLY: Prior exposure to a BRAF\n             inhibitor.\n\n          -  Part 1, Part 2 and BRAF-mutant patients in Part 4 ONLY: Known presence of\n             KRAS-mutation based on previous KRAS-testing. Note: Propsective KRAS testing is not\n             required. However, if the results of previous KRAS testing are known, they must be\n             used in assessing eligibility. KRAS testing will be performed retrospectively for all\n             patients.\n\n          -  Part 3: Prior exposure to EGFR inhibitors or an anti-EGFR antibody\n\n          -  Received an investigational or approved anti-cancer drug within 4 weeks, or within 5\n             half-lives (whichever is shorter) of the first dose of study drug(s). At least 14 days\n             must have passed between the last dose of prior investigational agent and the first\n             dose of study drug(s).\n\n          -  Part 3: Received more than one prior anti-cancer therapy in the metastatic setting,\n             exclusive of previous adjuvant regimens. Previous investigational anti-cancer therapy\n             in the metastatic setting is prohibited.\n\n          -  Current use of a prohibited medication or requirement to dose with any of these\n             medications during treatment with study drug(s).\n\n          -  Known Hepatitis B, or Hepatitis C infection.\n\n          -  Any major surgery, radiotherapy or immunotherapy within the 4 weeks prior to first\n             dose of study drug(s). Limited radiotherapy with in the 2 weeks prior to first dose of\n             study drug(s).\n\n          -  Chemotherapy regimens with delayed toxicity within the 3 weeks prior to first dose of\n             study drug(s). Chemotherapy regimens given continuously or on a weekly basis with\n             limited potential for delayed toxicity within 2 weeks prior to first dose of study\n             drug(s).\n\n          -  Unresolved toxicity greater than National Cancer Institute Common Terminology Criteria\n             for Adverse Events (NCI-CTCAE) version 4 Grade 1 from previous anti-cancer therapy,\n             with the exception of Grade 2 alopecia, Grade 2 neuropathy, or laboratory values that\n             are allowed per inclusion criteria.\n\n          -  History of retinal vein occlusion (RVO).\n\n          -  Presence of active gastrointestinal disease or other condition that will interfere\n             significantly with the absorption, distribution, metabolism or excretion of drugs.\n             Previous colectomy is acceptable.\n\n          -  Subjects with brain metastases are excluded, unless: All known lesions must be\n             previously treated with surgery or stereotactic radio-surgery, and Brain lesion(s), if\n             present, must be confirmed stable (i.e., no increase in lesion size) for >=90 days\n             prior to first dose of study drug(s). This must be documented with two consecutive MRI\n             or CT scans using contrast, and Asymptomatic with no corticosteroids requirement for\n             >=30 days prior to first dose of study drug(s), and No enzyme-inducing anticonvulsants\n             for >=14 days prior to first dose of study drug(s). In addition, for subjects that had\n             brain metastases but currently have no evidence of disease (NED), NED for >=12 weeks\n             is required and must be confirmed by two consecutive MRI or CT scans (using contrast)\n             separated by >=6 weeks, prior to randomization. Enrollment of a subject with brain\n             metastases who meet the above criteria requires approval of a GlaxoSmithKline (GSK)\n             Medical Monitor.\n\n          -  Psychological, familial, sociological or geographical conditions that do not permit\n             compliance with the protocol.\n\n          -  History or evidence of cardiovascular risk including any of the following: LVEF<LLN; A\n             QT interval corrected for heart rate using the Bazett's formula (QTcB;) ? 480\n             milliseconds (msec);.History or evidence of current clinically significant\n             uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for\n             >30 days prior to randomization are eligible. History of acute coronary syndromes\n             (including myocardial infarction and unstable angina), coronary angioplasty, or\n             stenting within 6 months prior to randomization. History or evidence of current >=\n             Class II congestive heart failure as defined by New York Heart Association (NYHA).\n             Treatment refractory hypertension defined as a blood pressure of systolic> 140\n             millimeter of mercury (mm Hg) and/or diastolic > 90 mm Hg which cannot be controlled\n             by anti-hypertensive therapy; Subjects with intra-cardiac defibrillators or permanent\n             pacemakers; Known cardiac metastases\n\n          -  Unstable pulmonary embolism, deep vein thrombosis, or other significant\n             arterial/venous thromboembolic event <=30 days before randomization. If on\n             anticoagulation, subject must be on stable therapeutic dose prior to randomization.\n\n          -  Subjects with a history of pneumonitis or interstitial lung disease (ILD).\n\n          -  Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs\n             chemically related to the study drug(s) or their excipients.\n\n          -  Pregnant or lactating female.\n\n          -  Unwillingness or inability to follow the procedures outlined in the protocol.\n\n          -  Uncontrolled diabetes or other medical condition that may interfere with assessment of\n             toxicity.Xx_NEWLINE_xXAny of the following prior therapies:\r\n* Chemotherapy =< 28 days prior to registration\r\n* Mitomycin C/nitrosoureas =< 42 days prior to registration\r\n* Immunotherapy =< 28 days prior to registration\r\n* Biologic therapy =< 28 days prior to registration\r\n* Radiation therapy =< 28 days prior to registration\r\n* Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation) =< 28 days prior to registration\r\n* Prior poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor therapyXx_NEWLINE_xXPatients must have recovered from the toxic effects of prior therapy, and there must be a minimum time of 28 days prior to registration from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions:\r\n* 14 days from administration of vincristine\r\n* 42 days from administration of nitrosoureas\r\n* 21 days from administration of procarbazineXx_NEWLINE_xXHistory/physical examination, including neurologic examination, within 14 days prior to registrationXx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of baselineXx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708Xx_NEWLINE_xXPatients must be 28 days from the end of the last induction course or at least 14 days from completion of previous methyltransferase inhibitor therapy (azacitidine or decitabine) at the time of registrationXx_NEWLINE_xXHave received treatment within the last 30 days prior to study entry with any drug that has not received regulatory approval for an indication at the time of study entryXx_NEWLINE_xXPlatelet count < 75,000/uL at the screening visit (note: patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic laboratory values obtained at the screening visit)Xx_NEWLINE_xXFor all participants, agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (<) 1% per year during the treatment period and for at least 90 days (30 days for women) after the last dose of venetoclax or 18 months after the last dose of obinutuzumab, whichever is longerXx_NEWLINE_xXdiscontinued previous monoclonal antibody therapy (except rituximab) or radioimmunotherapy administration for at least 60 days before study drug administration.Xx_NEWLINE_xXThe subject has received radiation therapy:\r\n* To the thoracic cavity or gastrointestinal tract within 3 months before the first dose of study treatment\r\n* To bone or brain metastasis within 14 days before the first dose of study treatment\r\n* To any other site(s) within 28 days before the first dose of study treatmentXx_NEWLINE_xXPatient must not have received any other investigational agents within 14 days prior to study enrollmentXx_NEWLINE_xXUsed any systemic steroids within 28 days of study treatmentXx_NEWLINE_xXExcept for steroid refractory or intolerant cases, participants must be receiving baseline systemic glucocorticoid therapy for cGVHD at study entry; the dose of steroids must be stable for 14 days prior to starting study drugXx_NEWLINE_xXAt the time of trial enrollment, participants may be receiving one or two other immunosuppressive therapies in addition to glucocorticoids; immunosuppressant doses must be stable for 14 days prior to starting study drug; monoclonal T or B cell antibodies must be discontinued at least 28 days before starting study drugXx_NEWLINE_xXPatients less than 30 days post HSCTXx_NEWLINE_xXInsufficient time for recovery from prior therapy:\r\n* Less than 28 days from any investigational agent, \r\n* Less than 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration), and \r\n* Less than 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count)Xx_NEWLINE_xXNo current or recent (within 28 days of enrollment) full dose anticoagulants or thrombolytic agentsXx_NEWLINE_xXNeurological deficits must be stable on a fixed or decreasing dose of dexamethasone for >= 7 days before study enrollmentXx_NEWLINE_xXFemale subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drugXx_NEWLINE_xXReceipt of another investigational drug within 14 days of enrollment.Xx_NEWLINE_xXThe participant has received radiation therapy:\r\n* To the thoracic cavity or gastrointestinal tract within 3 months of the first dose of study treatment\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatmentXx_NEWLINE_xXObtained within 14 days prior to registration: Potassium >= 3.5 mmol/LXx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must satisfy the following criteria to be enrolled in the study:\n\n          1. Must be ? 18 years at the time of signing the informed consent form\n\n          2. Must understand and voluntarily sign an informed consent document prior to any\n             study-related assessments/procedures\n\n          3. Must be able to adhere to the study visit schedule and other protocol requirements\n\n          4. Must have documented diagnosis of relapsed or refractory multiple myeloma and have\n             measurable disease (serum M-protein ? 0.5 g/dL or urine M-protein ? 200 mg/24 hours)\n\n          5. Must have had at least 1 prior anti-myeloma regimen\n\n          6. Must have documented progression as per the International Myeloma Working Group\n             uniform response criteria (Durie, 2006) during or after the last anti-myeloma regimen\n\n          7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2\n\n          8. Females of childbearing potential (FCBP) must agree to utilize two reliable forms of\n             contraception simultaneously or practice complete abstinence from heterosexual contact\n             for at least 28 days before starting study drug, while participating in the study\n             (including dose interruptions), and for at least 28 days after study treatment\n             discontinuation, and must agree to regular pregnancy testing during this timeframe\n\n          9. Females must agree to abstain from breastfeeding during study participation and for 28\n             following discontinuation from study treatment\n\n         10. Males must agree to use a latex condom during any sexual contact with FCBP while\n             participating in the study and for 28 days following discontinuation from study\n             treatment, even if he has undergone a successful vasectomy\n\n         11. Males must also agree to refrain from donating semen or sperm while on pomalidomide\n             and for 28 days after discontinuation from study treatment\n\n         12. All subjects must agree to refrain from donating blood while on study drug and for 28\n             days after discontinuation from study treatment\n\n         13. All subjects must agree not to share medication\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment:\n\n          1. Peripheral neuropathy ? Grade 2\n\n          2. Non-secretory multiple myeloma\n\n          3. Any of the following laboratory abnormalities:\n\n               -  Absolute neutrophil count (ANC) < 1,000/µL\n\n               -  Platelet count < 75,000/µL\n\n               -  Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)\n\n               -  Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human\n                  erythropoietin use is permitted)\n\n               -  Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or\n                  serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) > 3.0 x\n                  upper limit of normal (ULN)\n\n               -  Serum total bilirubin > 2.0 mg/dL\n\n          4. Prior history of malignancies, other than the disease being studied, unless the\n             subject has been free of the malignancy for ? 5 years from initiating study treatment,\n             with the following exceptions:\n\n               -  Basal cell carcinoma of the skin\n\n               -  Squamous cell carcinoma of the skin\n\n               -  Carcinoma in situ of the cervix\n\n               -  Carcinoma in situ of the breast\n\n               -  Incidental histologic finding of prostate cancer (T1a or T1b using the TNM\n                  [tumor, nodes, metastasis] clinical staging system).\n\n          5. Previous therapy with Pomalidomide\n\n          6. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone\n\n          7. Rash ? Grade 3 during prior thalidomide or lenalidomide therapy\n\n          8. Incidence of gastrointestinal disease that may significantly alter the absorption of\n             pomalidomide\n\n          9. Subjects with any one of the following:\n\n               -  Congestive heart failure (New York Heart Association Class III or IV)\n\n               -  Myocardial infarction within 12 months prior to starting study treatment\n\n               -  Unstable or poorly controlled angina pectoris, including Prinzmetal variant\n                  angina pectoris\n\n         10. Subjects who received any of the following within the last 14 days of initiation of\n             study treatment:\n\n               -  Plasmapheresis\n\n               -  Major surgery (kyphoplasty is not considered major surgery)\n\n               -  Radiation therapy (with the exception of radiation therapy to a pathological\n                  fracture site to enhance bone healing or to treat post-fracture pain that is\n                  refractory to narcotic analgesics)\n\n               -  Any anti-myeloma drug therapy\n\n         11. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer)\n             of initiating study treatment\n\n         12. Subjects with conditions requiring chronic steroid or immunosuppressive treatment,\n             such as rheumatoid arthritis, multiple sclerosis, and lupus, which likely need\n             additional steroid or immunosuppressive treatments in addition to the study treatment.\n             Includes subjects receiving corticosteroids (> 10 mg/day of prednisone or equivalent)\n             within 3 weeks prior to initiating study treatment\n\n         13. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment will not\n             be eligible to participate in this study\n\n         14. Any condition, including the presence of laboratory abnormalities, which places the\n             subject at unacceptable risk if he/she were to participate in the study\n\n         15. Any serious medical condition, laboratory abnormality, or psychiatric illness that\n             would prevent the subjects from signing the informed consent form\n\n         16. Pregnant or breastfeeding femalesXx_NEWLINE_xXFor pemetrexed arms: the ability to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexedXx_NEWLINE_xXAny prior therapy for castrate disease is acceptable except prior abiraterone, which is excluded; a minimum washout of 28 days for any other anticancer therapy prior to first dose of study drug is required\r\n* Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug\r\n* Denosumab or zoledronic acid are allowedXx_NEWLINE_xXPatients must be at least 28 days from last radiation therapy dose, surgery, or tumor embolization prior to the first dose of pazopanib/PCI-24781Xx_NEWLINE_xXIntravenous rituximab within 30 days of starting treatmentXx_NEWLINE_xXAdequate coagulation parameters (within 21 days prior to registration)Xx_NEWLINE_xXInclusion Criteria:\n\n          1. At least 18 years of age.\n\n          2. Ability to understand the purposes and risks of the study and has signed a written\n             informed consent form approved by the investigator's IRB/Ethics Committee.\n\n          3. Relapsed/refractory multiple myeloma for which no standard therapy options are\n             anticipated to result in a durable remission.\n\n          4. Receipt of at least two prior therapies as indicated by protocol\n\n          5. Subjects with measurable disease\n\n          6. ECOG performance status of less than or equal to 2\n\n          7. Acceptable liver function\n\n          8. Acceptable renal function\n\n          9. Acceptable hematologic status\n\n         10. For Part A, B, C subjects: Women of childbearing potential must have a negative serum\n             pregnancy test and women and men subjects must agree to use effective means of\n             contraception with their partner as indicated by protocol For Part D subjects: a\n             negative serum pregnancy test is required within 10- 14 days prior to initiating with\n             pomalidomide, AND a negative serum pregnancy test within 24 hours of starting\n             pomalidomide and must either commit to continued abstinence from heterosexual\n             intercourse or begin two acceptable methods of birth control at least 28 days before\n             she starts taking pomalidomide.\n\n             Women of childbearing potential must enroll into and follow all requirements of the\n             POMALYST REMS program, which includes adhering to the scheduled pregnancy testing.\n\n             Men must agree to use a latex or synthetic condom during sexual contact with women of\n             child bearing potential even if they have had a vasectomy.\n\n             All subjects must be counseled at a minimum of every 28 days about pregnancy\n             precautions and risks of fetal exposure, or when a female patient misses her period or\n             if there is any abnormality in her menstrual bleeding.\n\n         11. Subjects must adhere to the study visit schedule and other protocol requirements and\n             receive outpatient therapy and laboratory monitoring at the institute that administers\n             the study drug.\n\n        Exclusion Criteria\n\n        Subjects who meet any of the following exclusion criteria are not eligible to be enrolled\n        in this study:\n\n          1. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy\n             and skin changes.)\n\n          2. Waldenstrom's macroglobulinemia\n\n          3. Localized radiation therapy to only measurable disease site(s) within 2 weeks of\n             treatment\n\n          4. New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial\n             infarction within 6 months prior to Day 1, or unstable arrhythmia\n\n          5. Significant neuropathy (Grade 3 or 4, or Grade 2 with pain) at the time of enrollment\n             or within 14 days before enrollment\n\n          6. Symptomatic brain metastases (unless previously treated and well controlled for a\n             period of ? 3 months)\n\n          7. Severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the\n             investigator any physiological state leading to hypoxemia\n\n          8. Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without\n             complete recovery\n\n          9. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic\n             therapy within 14 days prior to the first dose\n\n         10. Previously treated malignancies, except for adequately treated non-melanoma skin\n             cancer (basal cell or squamous cell), in situ cancer, or other cancer from which the\n             subject has been disease-free for at least 5 years\n\n         11. Subjects who participated in an investigational drug or device study within 2 weeks\n             prior to study entry\n\n         12. Known or suspected active infection with HIV, hepatitis A, hepatitis B, or hepatitis C\n\n         13. Subjects who have exhibited allergic reactions to a similar structural compound,\n             biological agent, or formulation similar to TH-302, bortezomib (for subjects enrolled\n             in Part C only), pomalidomide (Part D), dexamethasone or pimonidazole\n\n         14. Females who are pregnant or breast-feeding\n\n         15. Concomitant psychiatric disease or medical condition that could interfere with the\n             conduct of the study, or that would, in the opinion of the investigator, pose an\n             unacceptable risk to the subject in this study\n\n         16. Unwillingness or inability to comply with the study protocol for any reason\n\n         17. Previous cytotoxic therapies for multiple myeloma within 3 weeks prior to study entry\n             (2 weeks for biologic, novel therapy or corticosteroids)\n\n         18. Subjects who have been on hormone replacement less than 2 months (subjects on hormone\n             replacement for at least 2 months will not be excluded provided the HRT regimen\n             remains unchanged during the conduct of the study).\n\n         19. Prior peripheral stem cell transplant within 12 weeks of the start of study\n\n         20. Epilepsy or other convulsive disorder requiring active management\n\n         21. Prior therapy with a pomalidomide-containing regimen\n\n         22. Subjects on strong inducers or strong inhibitors of cytochrome P450 CYP3A4 or CYP1A2\n\n         23. Any other medical condition that in opinion of investigator would place patient at\n             increased risk for toxicity during pomalidomide treatment (i.e. history of recurrent\n             or serious thromboembolic events)Xx_NEWLINE_xXLab data and clinical examination: Data within 28 days before the scheduled date of surgeryXx_NEWLINE_xXInclusion Criteria: (Dose-Escalation Phase)\n\n          1. For the dose-escalation phase, patients must have cytologically or histologically\n             proven advanced malignant solid tumors, with emphasis on CRPC.\n\n          2. Patients must be 18 years of age or older.\n\n          3. Patients must have a Zubrod (ECOG) performance status of 0-2.\n\n          4. Patients must have an estimated survival of at least 3 months.\n\n          5. Any prior chemotherapy must have been completed at least 4 weeks prior to start of\n             treatment. Prior radiation must have been completed at least 2 weeks prior to start of\n             therapy. Patients must have recovered from acute reversible side effects of prior\n             chemotherapy regimens or radiotherapy to < grade 1 (excluding alopecia, lymphopenia,\n             and hyperglycemia) according to the National Cancer Institute Common Terminology\n             Criteria for Adverse Events (NCI-CTCAE), version 4.0.\n\n          6. Radiographs (Xrays, CT scans, etc) to follow disease response or progression must have\n             been completed within 28 days prior to registration.\n\n          7. Patients must have adequate renal function as documented by a calculated creatinine\n             clearance of > 45 ml/min (see Appendix for formula for calculating creatinine\n             clearance).\n\n          8. Patients must have adequate liver functions: AST and ALT < 2.5 X upper limit of\n             normal, and bilirubin < upper limit of normal.\n\n        Inclusion Criteria: MTD Expansion Phase Cohort 1 - CRPC\n\n          1. All patients must have a histologic diagnosis of adenocarcinoma of the prostate which\n             is measurable or non-measurable.\n\n          2. Patients must have metastatic prostate cancer deemed to be unresponsive or refractory\n             to hormone therapy by one or more of the following (despite androgen deprivation and\n             antiandrogen withdrawal when applicable):\n\n               -  Progression of measurable disease assessed within 28 days prior to registration.\n\n               -  Progression of non-measurable disease assessed within 28 days prior to\n                  registration.\n\n               -  Rising PSA - Rising PSA is defined as at least two consecutive rises in PSA to be\n                  documented over a reference value (measure 1). The first rising PSA (measure 2)\n                  must be taken at least 7 days after the reference value. A third confirmatory PSA\n                  measure is required (2nd beyond the reference level) to be greater than the\n                  second measure, and it must be obtained at least 7 days after the 2nd measure. If\n                  this is not the case, a fourth PSA is required to be taken and be greater than\n                  the second measure. The patient must have a PSA ? 5 ng/ml in addition to\n                  increasing PSA to be eligible by rising PSA criteria alone. However, no minimum\n                  PSA is required for patients whose progression is based on measurable or\n                  non-measurable disease.\n\n          3. All patients must have a pre-study PSA obtained within 28 days prior to registration.\n\n          4. All patients must have had imaging studies within 28 days prior to registration. The\n             choice of imaging studies to follow disease will be at the discretion of the\n             investigator.\n\n          5. Patients must be offered the opportunity to participate in specimen banking for future\n             use (to include the serum and tissue correlative studies).\n\n          6. Patients must have been surgically or medically castrated. If method of castration is\n             LHRH agonists (leuprolide or goserelin) or LHRH antagonists, then the patient should\n             be willing to continue the use of LHRH agonists. Patients who have stopped treatment\n             should be willing to restart.\n\n          7. If the patient has been treated with non-steroidal antiandrogens (flutamide,\n             bicalutamide, nilutamide or ketoconazole), they must have been stopped at least 14\n             days prior to registration for ketoconazole and at least 28 days prior to registration\n             for flutamide, bicalutamide or nilutamide and the patients must have demonstrated\n             progression.\n\n          8. Prior, planned, or ongoing bisphosphonate therapy or denosumab is allowed.\n\n        Exclusion Criteria:\n\n        (Dose-Escalation Phase)\n\n          1. Pregnant or breastfeeding women. The effects of these drugs on the unborn fetus are\n             unknown. Documentation of a negative serum pregnancy test is required for all women of\n             reproductive potential.\n\n          2. Patient has a clinically significant concurrent illness. Patients must not have a\n             serious intercurrent medical or psychiatric illness, including serious active\n             infection.\n\n          3. Patient is currently enrolled in a different clinical study in which investigational\n             procedures are performed or investigational therapies are administered. Also, a\n             patient may not enroll in such clinical trials while participating in this study.\n\n          4. Patient has a history of allergy or hypersensitivity to the study drugs or a taxane.\n\n          5. Patient has serious medical risk factors involving any of the major organ systems such\n             that the investigator considers it unsafe for the patient to receive an experimental\n             research drug.\n\n          6. Prior therapy with ADI-PEG 20 or docetaxel.\n\n          7. Allergy to pegylated compounds or study drugs.\n\n        Exclusion Criteria: MTD Expansion Phase Cohort 1 - CRPC\n\n          1. Patient has a clinically significant concurrent illness. Patients must not have a\n             serious intercurrent medical or psychiatric illness, including serious active\n             infection.\n\n          2. Patient is currently enrolled in a different clinical study in which investigational\n             procedures are performed or investigational therapies are administered. Also, a\n             patient may not enroll in such clinical trials while participating in this study.\n\n          3. Patient has a history of allergy or hypersensitivity to the study drug or a taxane.\n\n          4. Patient has serious medical risk factors involving any of the major organ systems such\n             that the investigator considers it unsafe for the patient to receive an experimental\n             research drug.\n\n          5. Prior therapy with ADI-PEG 20 or docetaxel.\n\n          6. Allergy to pegylated compounds.Xx_NEWLINE_xXPrior systemic therapy within 28 days of study enrollmentXx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of baselineXx_NEWLINE_xXNote: laboratory tests required for eligibility must be completed within 4 weeks prior to study entry; baseline measurements in the CNS must be documented from tests within 14 days of study entry; other non-laboratory tests must be performed as indicatedXx_NEWLINE_xXHematopoietic Status (within 30 days prior to randomization):Xx_NEWLINE_xXHepatic Status (within 30 days prior to randomization):Xx_NEWLINE_xXRenal Status (within 30 days prior to randomization): a) Creatinine no greater than 1.5 times ULNXx_NEWLINE_xXUse of other non-steroidal anti-inflammatory drugs (such as ibuprofen) exceeding 4 days per month, in the prior 6 weeks.Xx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of baseline.Xx_NEWLINE_xXPrior systemic therapy within 14 days of initiating protocol treatmentXx_NEWLINE_xXTreatment with proton pump inhibitor (PPI); patients on PPI therapy prior to enrollment must stop using the PPI for at least 4 days prior to the first dose of MLN8237Xx_NEWLINE_xXSubjects must be free of neurologic symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroids for ?10 days prior to initiation of study treatmentXx_NEWLINE_xXPrior cetuximab, panitumumab, or other monoclonal antibody therapy allowed if given 28 days prior to the 1st infusion of armed T cellsXx_NEWLINE_xXUntransfused platelet count >= 75000/mL (obtained =< 14 days prior to registration)Xx_NEWLINE_xXRecent prior chemotherapy:\r\n* Alkylators (e.g. melphalan, cyclophosphamide) =< 14 days prior to registration\r\n* Anthracyclines =< 14 days prior to registration\r\n* High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide) =< 7 days prior to registrationXx_NEWLINE_xXHistory/physical examination within 28 days prior to registrationXx_NEWLINE_xXHave received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectivelyXx_NEWLINE_xXReceived investigational drugs within the 14 days before enrollmentXx_NEWLINE_xXAll necessary baseline studies for determining eligibility must be obtained within 14 days prior to enrollment. Serum pregnancy tests (sensitivity of at least 25 mIU/mL), for females of childbearing potential (WCBP) must be completed. The first test must be performed within 10-14 days, and the second test within 24 hours prior to initiation of lenalidomide.Xx_NEWLINE_xXAble to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (except for those prescribed as part of the study)Xx_NEWLINE_xXReceived any investigational drugs within the 14 days before 1st dose of fludarabineXx_NEWLINE_xXConcurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicityXx_NEWLINE_xXProtocol treatment must begin within 5 consecutive days after registrationXx_NEWLINE_xXUse of any investigational anti-cancer drug within 14 days or 5-half-lives (minimum 14 days), prior to start of study medication (Note: Dabrafenib monotherapy within 14 days prior to starting combination therapy is allowed for crossover subjects in Cohort A);Xx_NEWLINE_xXAny experimental therapy ? 28 days prior to randomizationXx_NEWLINE_xXReceived platelet transfusion within 14 days prior to Screening evaluations.Xx_NEWLINE_xXIntake of any herbal preparations or medications (e.g., including, but not limited to, Saint-Johns wort and ginkgo biloba) and dietary supplements within 7 days prior to first dose of study drugXx_NEWLINE_xXPatients unable or unwilling to discontinue (and substitute if necessary) use of prohibited drugs for at least 30 days prior to day 1 of FOLFIRI initiationXx_NEWLINE_xXAll necessary baseline studies for determining eligibility must be obtained within 42 days of registration unless otherwise statedXx_NEWLINE_xXThe above tests must be obtained within 14 days of study treatmentXx_NEWLINE_xXPatients require ongoing therapy with non-steroidal anti-inflammatory drugs (NSAIDs), intravenous (i.v.) vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from NSAIDs from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less)Xx_NEWLINE_xXPatients must have a complete physical examination and medical history within 28 days prior to registrationXx_NEWLINE_xXPatient has received other investigational drugs within 14 days prior to enrollmentXx_NEWLINE_xXPatient must have undergone ASCT between 60 and 90 days prior to study registrationXx_NEWLINE_xXPatient has used any other anti-cancer drug or therapy, including experimental, within 30 days of initiation of lenalidomide treatment (radiation therapy is allowed within 30 days)Xx_NEWLINE_xXReceived prior TKI treatment within 7 days prior to receiving the first dose of ponatinib, or have not recovered from adverse events (except alopecia) due to agents previously administered.Xx_NEWLINE_xXFor CML chronic phase (CP) and accelerated phase (AP) patients, received hydroxyurea or anagrelide within 24 hours prior to receiving the first dose of ponatinib; interferon, cytarabine, or immunotherapy within 14 days prior to first dose of ponatinib; or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib.Xx_NEWLINE_xXFor CML blast phase (BP) patients, received chemotherapy within 14 days prior to the first dose of ponatinib.Xx_NEWLINE_xXFor Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of ponatinib; or vincristine within 7 days prior to the first dose of ponatinib; or received other chemotherapy within 14 days prior to the first dose of ponatinib.Xx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of baselineXx_NEWLINE_xXEnrollment within 14 days of the completion of End of Treatment Visit of the original studyXx_NEWLINE_xXPatient has received other investigational drugs with 14 days before enrollmentXx_NEWLINE_xXUse of any other experimental drug or therapy other than carfilzomib and pomalidomide within 28 days of treatment start on this protocolXx_NEWLINE_xXPatients must be within 30 days of completing induction therapy.Xx_NEWLINE_xXPatient has received other investigational drugs with 14 days before enrollmentXx_NEWLINE_xXUse of any other experimental anti-cancer drug or therapy within 28 days of initiation of the study drugXx_NEWLINE_xXSubject is receiving medication(s) that might affect immune function; use of H2 antagonists are prohibited as are all antihistamines five days before and five days after each injection of study vaccine; however, NSAIDS including COX-2 inhibitors, acetaminophen or aspirin are permittedXx_NEWLINE_xXAll subjects must agree to stop the use of any known CYP2C8 substrates with a narrow therapeutic window within the 14 days prior to receiving the first dose of AMG 232 and during protocol AMG 232 treatment (weeks 1-5)Xx_NEWLINE_xXAll subjects are required to submit a list of medications consumed within 14 days prior to receiving the first dose of AMG232 and during the protocol AMG232 treatment (weeks 1-5)Xx_NEWLINE_xXPatients should agree to not donate blood while participating in this study or for at least 90 days following the last infusion of durvalumab or tremelimumabXx_NEWLINE_xXOne course of hypomethylating agent therapy (i.e.; up to 7 doses of azacitidine or 3-5 days of decitabine) within 30 days prior to enrollment (Day 1)Xx_NEWLINE_xXUse of experimental drugs ? 30 days prior to screeningXx_NEWLINE_xXLymphocyte count >= 300/uL (obtained within 14 days prior to the first study treatment [course 1, day 1])Xx_NEWLINE_xXConcurrent anticancer treatment (e.g., cytoreductive therapy, radiotherapy except for palliative bone-directed radiotherapy, immune therapy, or cytokine therapy except for erythropoietin) within 28 days before start of trial treatment; major surgery within 28 days before start of trial treatment (excluding prior diagnostic biopsy); use of hormonal agents within 7 days before start of trial treatment, except for subjects with castration-resistant prostate cancer (CRPC), who may remain on treatment with luteinizing hormone-releasing hormone agonists or antagonists; or use of any investigational drug within 28 days before start of trial treatment. Note: Small molecule or antibody targeted therapy is permissible <14 days from start of trial treatment.Xx_NEWLINE_xXIs neurologically stable without the need for steroids for ?7 days before first dose of study treatment.Xx_NEWLINE_xXUse of aspirin (>325 mg/day) within 10 days prior to the first dose of study treatment. The use of prophylactic therapeutic anti-coagulants are allowed provided that INR or aPTT are within therapeutic limits (according to the medical standard of the enrollment institution) and patient has been on a stable dose of anticoagulants for at least two weeks prior to the first dose of study treatment.Xx_NEWLINE_xXPlan to father a child while enrolled in this study or within 90 days after the last dose of study drug.Xx_NEWLINE_xXHave peripheral blood levels of IgG anti-?-glucan antibody (ABA) of ? 20 mcg/mL as determined by an ELISA test within 28 days prior to start of study treatmentXx_NEWLINE_xXHave adequate coagulation functioning within 15 days prior to start of study treatment, defined by either of the following criteria:Xx_NEWLINE_xXTreatment must begin within 90 days of the last dose of immunochemotherapyXx_NEWLINE_xXInclusion Eligibility Criteria\n\n        Age Patients must be ? 1 and ? 21 years of age at the time of enrollment.\n\n        Diagnosis Patients must have a diagnosis of acute lymphoblastic leukemia (ALL) with ? 5%\n        blasts in the bone marrow (M2 or M3), with or without extramedullary disease (excluding\n        active Central Nervous System 3 involvement).\n\n        Subjects with first relapse must have an M3 marrow to be eligible.\n\n        Performance Level Karnofsky > 50% for patients > 16 years of age and Lansky > 50% for\n        patients ? 16 years of age.\n\n        Prior Therapy\n\n          1. Patients must have recovered from the acute toxic effects (? Grade 2 or baseline) of\n             all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study,\n             unless otherwise specified. Subjects with disease related cytopenias will be eligible.\n\n          2. Patients must have relapsed disease after attaining at least a first remission. They\n             may be in first to third relapse.\n\n          3. Patients with Philadelphia chromosome t(9;22) positive disease must have received at\n             least two prior tyrosine kinase inhibitors.\n\n          4. Patients who have experienced their relapse after a Hematopoietic stem cell\n             transplantation (HSCT) are eligible, provided they have no evidence of\n             graft-versus-host disease (GVHD) and are at least 100 days post-transplant at the time\n             of enrollment.\n\n          5. Prior anthracycline lifetime cumulative exposure: Patients must have less than 320\n             mg/m2 (or 400 mg/m2 if prior cardioprotection) lifetime exposure of anthracycline\n             chemotherapy.\n\n          6. Hematopoietic growth factors: It must have been at least seven days since the\n             completion of therapy with granulocyte colony-stimulating factor (GCSF) or other\n             growth factors at the time of enrollment. It must have been at least 14 days since the\n             completion of therapy with pegfilgrastim (Neulasta®).\n\n          7. Biologic anti-neoplastic agents: At least seven days after the last dose of a biologic\n             agent. For agents that have known adverse events occurring beyond seven days after\n             administration, this period must be extended beyond the time during which adverse\n             events are known to occur. The duration of this interval must be discussed with the\n             study chair or vice chair.\n\n          8. Monoclonal antibodies: At least three half-lives (or 30 days—whichever is longer) of\n             the antibody must have elapsed after the last dose of monoclonal antibody. (e.g.,\n             Rituximab = 66 days, Epratuzumab = 69 days)\n\n          9. Immunotherapy: At least 30 days after the completion of any type of immunotherapy,\n             e.g. tumor vaccines, chimeric antigen receptor T-cells.\n\n         10. Recent prior chemotherapy: At least 14 days after standard vincristine and the\n             completion of any type of chemotherapy induction regimen. At least 3 weeks after\n             radiation therapy. At least 30 days after the completion of any investigational\n             neoplastic agent is also required. An investigational agent is defined as any drug\n             that is not approved and licensed for sale by the FDA for institutions in the United\n             States, by Health Canada for institutions in Canada and by The Therapeutic Goods\n             Administration for institutions in Australia.\n\n        Exceptions:\n\n          1. There is no time restriction in regard to prior intrathecal chemotherapy provided\n             there is complete recovery from any acute toxic effects of such; it is allowable to\n             enroll a patient that has received IT Cytarabine (ARA-C), IT Methotrexate (MTX) or\n             triple IT therapy within 14 days of enrollment as part of their evaluation to diagnose\n             disease relapse. The IT therapy given within 14 days of initiation of protocol\n             specified chemotherapy, will substitute for the day 1 IT.\n\n          2. Subjects with rapidly progressive disease may receive hydroxyurea until they begin\n             study therapy;\n\n          3. Patients who relapse while on maintenance-type ALL therapy or are receiving\n             maintenance therapy for disease stabilization will not require a wash-out period\n             before entry into this study. However, there must be at least 14 days after any dose\n             of standard vincristine.\n\n        Renal and Hepatic Function\n\n          1. Renal function: Patient's serum creatinine must be ? 1.5 x institutional upper limit\n             of normal (ULN) according to age. If the serum creatinine is greater than 1.5 times\n             normal, the patient must have a calculated creatinine clearance or radioisotope\n             glomerular filtration rate (GFR) ? 70milliliter/min/1.73m2. Alternatively, a 24-hour\n             creatinine clearance may also be used.\n\n          2. Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\n             must be < 3 x institutional upper limit of norm ULN. Total bilirubin must be ? 1.5 x\n             ULN (except in the case of subjects with documented Gilbert's disease ? 5 × ULN).\n\n        Cardiac Function Patients must have a shortening fraction ? 27% or an ejection fraction ?\n        55% by echocardiogram, cardiac MRI or multigated acquisition scan (MUGA).\n\n        Reproductive Function\n\n          1. Female patients must not be pregnant and those of childbearing potential must have a\n             negative urine or serum pregnancy test confirmed within one week prior to enrollment.\n\n          2. Female patients with infants must agree not to breastfeed their infants while on this\n             study.\n\n          3. Male and female patients of childbearing potential must agree to use an effective\n             method of contraception during the study.\n\n        Exclusion Eligibility Criteria\n\n        Patients will be excluded if they have active Central Nervous System (CNS) 3 status.\n\n        Patients will be excluded if they have isolated testicular disease.\n\n        Patients with biphenotypic leukemia will be excluded.\n\n        Patients will be excluded if they have refractory disease or fourth relapse and beyond,\n        defined as any of the following:\n\n          1. Patients with four or more prior induction attempts,\n\n          2. Refractory disease after first or greater relapse and a re-induction attempt,\n\n          3. Failing to go into remission from original diagnosis after two previous induction\n             attempts.\n\n        Patients will be excluded if they have previously received Marqibo®.\n\n        Patients will be excluded if they have a known allergy to any of the drugs used in the\n        study, with the exception that patients with an allergy to PEG-asparaginase who can receive\n        Erwinia are eligible.\n\n        Patients will be excluded if they have active, uncontrolled systemic fungal, bacterial,\n        viral or other infection despite appropriate antibiotics or other treatment.\n\n        Patients who require azole antifungal agents will be excluded. Azoles must be discontinued\n        at least one week prior to the start of Marqibo®.\n\n        Patients will be excluded if there is a plan to administer non-protocol chemotherapy,\n        radiation therapy, another investigational agent or immunotherapy during the study period.\n\n        Patients with pre-existing, persistent grade 2 or greater sensory or motor neuropathy from\n        any cause will be excluded.\n\n        Patients will be excluded if they have Down syndrome, significant concurrent disease,\n        illness, psychiatric disorder or social issue that would compromise patient safety or\n        adherence with the protocol treatment or procedures or interfere with consent, study\n        participation, follow up, or interpretation of study results.\n\n        Patients positive for human immunodeficiency virus (HIV) will be excluded due to the\n        increased risk of complications such as severe infection and unknown interaction of\n        Marqibo® with antiretroviral drugs.\n\n        Active hepatitis B or C infection as defined by seropositive for hepatitis B (hepatitis B\n        surface antigen (HBsAg)) or hepatitis C and elevated liver transaminases (defined as above\n        the ULN per the institution normal ranges).Xx_NEWLINE_xXLaboratory values obtained ? 14 days prior to randomization:Xx_NEWLINE_xXRadiotherapy within 14 days prior to the first dose of study drug; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the first dose of the study medicationsXx_NEWLINE_xXPatients with hemoptysis within 28 days prior to entering the studyXx_NEWLINE_xXPatients must have sufficient time for recovery from prior therapy: 28 days from any investigational agent, 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration), and 7 days for patients who received metronomic chemotherapy or non-cytotoxic agents, e.g., bevacizumab, interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count)Xx_NEWLINE_xXPatients with HL who have received ASCT in the previous 30-45 daysXx_NEWLINE_xXPatients must not have received any other investigational agents within 30 days prior to vaccination.Xx_NEWLINE_xXOngoing ? Grade 2 toxicities from previous cancer therapies unless specifically allowed in the Inclusion/Exclusion criteria. Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551Xx_NEWLINE_xXUse of hydroxyurea within 7 days prior to screening labsXx_NEWLINE_xXPatients must be expected to have disease controlled for at least 60 days after HCTXx_NEWLINE_xXPatients who have received any investigational agent, chemotherapy, interferon-?, or 2-chlorodeoxyadenosine (2-CdA, cladribine) within 30 days prior to first doseXx_NEWLINE_xXEither commit to continued abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.Xx_NEWLINE_xXREGISTRATIONXx_NEWLINE_xXPhysical examination, and scans needed for tumor assessment must be performed within 90 days prior to registrationXx_NEWLINE_xXPrior treatment with dose dense regimens of temozolomide is not allowed (e.g, 7 days on/7 days off, 21 day/28 day and daily low dose continuous dosing). However, prior treatment with standard day 1-5 dosing in the adjuvant setting and low dose daily dosing as part of chemoradiation therapy are allowedXx_NEWLINE_xXLess than 28 days since last treatment used to treat the diseaseXx_NEWLINE_xXPatient has received other investigational drugs with 14 days before enrollment.Xx_NEWLINE_xXTreatment with hydroxyurea, busulfan, cytoreductive agents other than frontline TKI, or an investigational agent within 28 days of registration; patients who are on alpha-interferon as primary therapy are not eligibleXx_NEWLINE_xXPatient has not received other investigational drugs with 14 days before enrollmentXx_NEWLINE_xX14 days must have elapsed since the completion of myelosuppressive therapy; individuals may have received any of the following medications within 14 days without a “wash-out” period:\r\n* Hydroxyurea\r\n* Intrathecal chemotherapy with methotrexate, hydrocortisone and/or cytarabineXx_NEWLINE_xXAt least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the principal investigatorXx_NEWLINE_xXFemale subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.Xx_NEWLINE_xXFemale subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.Xx_NEWLINE_xXMale subject must not donate sperm starting at Screening and throughout the study period and for 90 days after the final study drug administration.Xx_NEWLINE_xXSubject has received blood transfusions or hematopoietic factor therapy within 14 days prior to the first dose of study drug.Xx_NEWLINE_xXSubject has received potent CYP 3A4 inhibitors within 7 days prior to first dose of study drug or proton pump inhibitors such as omeprazole within 14 days prior to first dose of study drug.Xx_NEWLINE_xXMonoclonal antibodies within 28 daysXx_NEWLINE_xXProteasome inhibitors within 14 daysXx_NEWLINE_xXImmunomodulatory agents within 7 daysXx_NEWLINE_xXTherapy with herbal products known to effect PSA, or estrogen within 30 days prior to the start of study medicationXx_NEWLINE_xXUse of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medicationXx_NEWLINE_xXAny major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to randomization; daily or weekly chemotherapy (with the exception of hydroxyurea) without the potential for delayed toxicity within 14 days prior to randomization unless there is evidence of rapidly progressive diseaseXx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must satisfy the following criteria to be enrolled in the study:\n\n          1. Subject has an eligible disease:\n\n               -  Primary Acute myeloid leukemia (AML) induction failure: no Complete Remission\n                  (CR) after 2 or more induction attempts or\n\n               -  Relapsed AML: not in CR after 1 or more cycles of standard re-induction\n                  chemotherapy\n\n                    -  For relapsed subjects > 60 years of age, the 1 cycle of standard\n                       re-induction chemotherapy is not required if either of the following\n                       criteria is met:\n\n                    -  relapse within 6 months of last chemotherapy\n\n                    -  blast count <30% within 10 days of starting this protocol therapy or\n\n               -  Secondary AML (MDS transformation or treatment related):\n\n             or\n\n             • AML relapsed > 2 months after transplant Subjects with prior central nervous system\n             (CNS) involvement are eligible provided that it has been treated and Cerebrospinal\n             fluid (CSF) is clear for at least 2 weeks prior to Visit 1.\n\n          2. Subject is ? 18 and ? 70 years of age at the time of signing the informed consent form\n             (ICF).\n\n          3. Subject must understand and voluntarily sign an ICF prior to any study-related\n             assessments/procedures being conducted.\n\n          4. Subject is willing and able to adhere to the study schedule and other protocol\n             requirements.\n\n          5. Karnofsky Performance Status > 50%.\n\n          6. Ability to be off prednisone and other immunosuppressive drugs for at least 3 days\n             prior to the PNK-007 cell infusion.\n\n          7. Female of childbearing potential (FCBP) must:\n\n             a. Have two negative pregnancy tests as verified by the Investigator prior to starting\n             study therapy. She must agree to ongoing pregnancy testing during the course of the\n             study, and after the end of study treatment. This applies even if the subject\n             practices true abstinence from heterosexual contact.\n\n          8. Either commit to true abstinence from heterosexual contact or agree to use, and be\n             able to comply with, effective contraception without interruption, 28 days prior to\n             starting PNK-007, during the study therapy (including dose interruptions), and for 28\n             days after discontinuation of study therapy. Male subjects must: a. Practice true\n             abstinence or agree to use a condom during sexual contact with a pregnant female or a\n             female of childbearing potential while participating in the study, during dose\n             interruptions and for at least 28 days following PNK-007 discontinuation, even if he\n             has undergone a successful vasectomy.\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment:\n\n          1. Subject has any significant medical condition, laboratory abnormality, or known\n             psychiatric illness that would prevent the subject from participating in the study.\n\n          2. Subject has any condition including the presence of laboratory abnormalities which\n             places the subject at unacceptable risk if he or she were to participate in the study.\n\n          3. A subject has any condition that confounds the ability to interpret data from the\n             study.\n\n          4. Subject has a body weight exceeding 120kg.\n\n          5. Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or\n             alkaline phosphatase ? 2.5 x the upper limit of normal (ULN) at screening.\n\n          6. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at screening\n             calculated using the Modification of Diet in Renal Disease Study equation or history\n             of an abnormal eGFR < 60 and a decline of > 15 mL/min/1.73 m2 below normal in the past\n             year.\n\n          7. Subject has a bilirubin level > 2 mg/dL (unless subject has known Gilbert's disease)\n             at screening.\n\n          8. Subject has had prior treatment with biologic antineoplastic agents no less than 7\n             days before PNK-007 infusion and at least 5 half lives. For agents that have known\n             Adverse Events (AEs) occurring beyond 7 days after administration (ie, monoclonal\n             antibodies), this period must be extended beyond the time during which acute AEs are\n             known to occur. An exception to this criteria is hydroxyurea which can be given\n             throughout the Screening/Baseline Period up to the time of the pre-conditioning\n             treatment.\n\n          9. Subject has bi-phenotypic acute leukemia.\n\n         10. Subject has had a transplant < 60 days prior to Visit 1 (Screening/Baseline visit).\n\n         11. Subject has had treatment for graft-versus-host disease < 30 days prior to Visit 1\n             (Screening/Baseline visit).\n\n         12. Subject is pregnant or breastfeeding.\n\n         13. Subject has new or progressive pulmonary infiltrates or pleural effusion large enough\n             to be detected by chest x-ray or Computed tomography (CT) scan.\n\n         14. Subject has active autoimmune disease other than controlled connective tissue disorder\n             or those who are not on active therapy.\n\n         15. Subject is HIV positive.\n\n         16. Subject has a history of malignancy except primary, secondary, or relapsed Acute\n             myeloid leukemia (AML), or excised and cured non-melanoma skin cancer, or cervical\n             carcinoma in situ that was surgically ablated more than 5 years prior to PNK-007\n             infusion.\n\n         17. Subject has a history of severe asthma and is presently on chronic medications or has\n             a history of other symptomatic pulmonary disease.\n\n         18. Untreated chronic infection or treatment of any infection with systemic antibiotics\n             within 2 weeks prior to dosing with PNK-007.\n\n         19. Subject has any other organ dysfunction (CTCAE Version 4.03 Grade 3) that will\n             interfere with the administration of the therapy according to this protocol.\n\n         20. Subject has a resting left ventricular ejection fraction (LVEF) of < 35% obtained by\n             echocardiography or multigated acquisition scan (MUGA).Xx_NEWLINE_xXOngoing infection with, or treatment or prophylaxis for, CMV within the past 28 days.Xx_NEWLINE_xXTherapeutic or experimental monoclonal antibodies in last 60 days prior registration.Xx_NEWLINE_xXRecent infection requiring a course of systemic anti-infectives that was completed =< 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection [UTI])Xx_NEWLINE_xXHistory/physical examination within 60 days prior to registration to document cervical tumor size and stageXx_NEWLINE_xXThe donor has donated plasma within 7 days before screening or has donated blood within 56 days before screening.Xx_NEWLINE_xXUse of drugs that might pose a risk of a drug-drug interaction within 4-7 days before the start of study therapy.Xx_NEWLINE_xXAll subjects must have radiographically assessable disease per RECIST v1.1 obtained by imaging within 28 days prior to registration.Xx_NEWLINE_xXInclusion Criteria - All Phases:\n\n          1. Males and females ?18 years of age;\n\n          2. Eastern Cooperative Oncology Group (ECOG) Performance Status of ?1\n\n          3. Acceptable bone marrow and organ function at screening as described below:\n\n               1. ANC ? 1,500/µL;\n\n               2. Platelet count ? 100,000/µL;\n\n               3. Total bilirubin ? 1.5 × ULN or ? 3.0 × ULN for subjects with hereditary benign\n                  hyperbilirubinemia;\n\n               4. AST (SGOT) ? 3 × ULN (? 5 × ULN if liver metastases are present);\n\n               5. ALT (SGPT) ? 3 × ULN (? 5 × ULN if liver metastases are present);\n\n               6. Serum creatinine ? 1.5 mg/dL or a measured creatinine clearance ³ 60 mL/min\n                  according to Cockcroft-Gault formula\n\n          4. Left ventricular ejection fraction informed (LVEF) ? 55%;\n\n          5. Ability to swallow and retain oral medications;\n\n          6. Negative serum beta-human Chorionic Gonadotropin (?-hCG) test in women of childbearing\n             potential (WOCBP); Note, subject must agree to use dual barrier contraceptive methods;\n             and\n\n          7. Willing and able to provide written informed consent and comply with the requirements\n             of the study;\n\n          8. Phase 1a Dose Escalation only - Histologically confirmed advanced solid tumor for\n             which standard therapy does not exist or is no longer effective\n\n          9. Food Effect Stage - willing and able to ingest a standard meal\n\n         10. Phase 1b All Expansion Cohorts - Evidence of measurable disease per RECIST, v1.1.\n             Measurable disease is defined as a lesion that can be accurately measured in at least\n             1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computed\n             tomography (CT) scan;\n\n         11. Phase 1b All Expansion Cohorts - Prior treatment with embolization or ablative\n             therapies is allowed if measurable disease remains outside of the treated area or if\n             there is definitive progression in the treated lesions. There is no limit on the\n             number of prior procedures;\n\n         12. Phase 1b Dose Expansion RAS Mutated mCRC Arm only - Histologically confirmed\n             colorectal cancer with a K-RAS or N-RAS mutation in exons 2,3 and 4 that is metastatic\n             or unresectable;\n\n         13. Phase 1b Dose Expansion RAS Mutated mCRC Arm only - At least 2 prior systemic\n             therapies for the treatment of metastatic colorectal cancer. Neo-adjuvant and adjuvant\n             therapies may not be counted as part of the prior therapy requirements. At least 7\n             subjects should be naïve to treatment with regorafenib;\n\n         14. Phase 1b Optional Dose Expansion Advanced RCC Arm only - Histologically confirmed\n             metastatic renal cell carcinoma;\n\n         15. Phase 1b Optional Dose Expansion Advanced RCC Arm only - Must have received 2 prior\n             therapies for metastatic RCC, including a vascular endothelial growth factor receptor\n             (VEGFR) tyrosine kinase inhibitor (TKI) and an immune checkpoint inhibitor (ie\n             anti-PD-1) (if approved and available for commercial use in the local country). At\n             least 7 subjects should be naïve to treatment with prior inhibitors of mammalian\n             target of rapamycin (mTOR) (eg. everolimus);\n\n         16. Phase 1b Optional Dose Expansion pNET Arm only - Histologically confirmed low-grade or\n             intermediate-grade, unresectable or metastatic pNET tumor for which standard therapy\n             does not exist or is no longer effective. Functional and non-functional tumors can be\n             included;\n\n         17. Phase 1b Optional Dose Expansion RAS-MAPK Pathway Mutation Arm only - Histologically\n             confirmed malignancy with a RAS-MAPK pathway mutation that is metastatic or\n             unresectable and for which standard therapy does not exist or is no longer effective.\n             At least 10 subjects with non-small cell lung cancer (NSCLC) are to be enrolled in\n             this arm.\n\n        Exclusion Criteria - All Phases\n\n          1. Any prior treatment (with the exception of somatostatin analogues, which are allowed\n             before and during the study in pNET subjects at the investigator discretion in pNET\n             subjects) such as chemotherapy, immunomodulatory drug therapy, anti-neoplastic\n             hormonal therapy (unless dose has been stable for 3 months prior to Baseline and will\n             remain stable during the study), immunosuppressive therapy, or corticosteroids (unless\n             administered to prevent contrast material reactions during radiographic procedures)\n             received within the past 28 days or 5 half-lives, whichever is shorter;\n\n          2. Presence of an acute or chronic toxicity resulting from prior chemotherapy, with the\n             exception of alopecia, that has not resolved to ? grade 1, as determined by NCI CTCAE\n             v 4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html);\n\n          3. Received radiotherapy within the last 21 days (limited palliative radiation is allowed\n             if ? 14 days prior);\n\n          4. Subjects with primary brain tumors or known central nervous system (CNS) metastases;\n\n          5. Major surgery < 28 days from the start of treatment (major surgery is defined as a\n             procedure requiring general anesthesia);\n\n          6. Minor surgery <14 days from the start of treatment (insertion of a vascular access\n             device is not considered major or minor surgery);\n\n          7. Active infection requiring systemic therapy;\n\n          8. Known to be human immunodeficiency virus (HIV) positive or have an acquired\n             immunodeficiency syndrome-related illness;\n\n          9. Uncontrolled congestive heart failure, angina, myocardial infarction, cerebrovascular\n             accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack,\n             or pulmonary embolism within 3 months prior to initiation of study drug;\n\n         10. History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of\n             any grade, or persistent prolongation of the QTc (Fridericia) interval to > 450 msec\n             for males or > 470 msec for females;\n\n         11. History of esophageal bleeding due to varices;\n\n         12. Gastrointestinal disease that may interfere with the absorption of orally-administered\n             drugs;\n\n         13. History of inflammatory bowel disease or other illness resulting in chronic diarrhea;\n\n         14. Known achlorhydria or history of gastrointestinal surgery that could reduce the\n             acidity of the stomach;\n\n         15. Acute pancreatitis or cholecystitis within 6 months prior to Baseline;\n\n         16. Cirrhosis with severe liver dysfunction (Child-Pugh Class B or C);\n\n         17. Previous or concomitant malignancy, except for basal-cell or squamous cell carcinoma\n             of the skin or carcinoma-in-situ of the uterine cervix. Subjects with other\n             malignancies are eligible if they have remained disease free for at least 2 years\n             prior to study entry;\n\n         18. Any severe, acute, or chronic medical or psychiatric condition, or laboratory\n             abnormality that may increase the risk associated with study participation or study\n             drug administration, may interfere with the informed consent process and/or with\n             compliance with the requirements of the study, or may interfere with the\n             interpretation of the study results and, in the Investigator's opinion, would make the\n             subject inappropriate for entry into this study;\n\n         19. Use of any investigational agents within 28 days or 5 half-lives (whichever is\n             shorter) prior to Baseline;\n\n         20. A condition that is expected to require concomitant use of any medication listed as\n             prohibited while on study;\n\n         21. Pregnant or lactating female;\n\n         22. Women of childbearing potential, or men who partner with a woman of childbearing\n             potential, unless they agree to use dual barrier contraceptive methods which, in the\n             Investigator's opinion, are effective and adequate for that subject's circumstances\n             while on study drug and for 3 months afterward;\n\n         23. Grade 3 or 4 eye disorder at study entry, unless stable and longstanding (>3 months)\n             and unlikely to interfere with protocol-required ophthalmology assessments;\n\n         24. Phase 1b Optional Dose Expansion pNET Arm only - Poorly differentiated pNET;\n\n         25. Phase 1b Optional Dose Expansion RAS-MAPK Pathway Mutation Arm only - Subjects with\n             primary pancreatic cancer or primary RAS mutated colorectal cancer.Xx_NEWLINE_xXOther anti-cancer therapy up to 14 days prior to enrollment, with the exception of hydroxyurea, which can be given up to 4 days prior to enrollment.Xx_NEWLINE_xXNon-study related surgical procedures less than or equal to 7 days prior to administration of study drug. In all cases, the patient must be sufficiently recovered and stable before treatment administration.Xx_NEWLINE_xXInability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or for 2 days (short half-life, if CrCL <80 mL/min) before pemetrexed dosing and until 2 days after pemetrexed dosingXx_NEWLINE_xXsteroids are currently not required and more than 14 days since last steroid treatmentXx_NEWLINE_xXFrench subjects: The French subject has participated in any study using an investigational study treatment(s) during the previous 28 days.Xx_NEWLINE_xXStable brain metastases either treated or being treated with a stable dose of steroids/ anticonvulsants, with no dose change within 28 days prior to the first dose of study drug, will be allowed.Xx_NEWLINE_xXBiologic (anti-neoplastic) therapy: It must be at least 7 days after last does of biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chairXx_NEWLINE_xXPatients will be excluded if they have had any positive fungal culture in the last 30 days prior to enrollment.Xx_NEWLINE_xXPatients must suspend the use of P450 inducing or P450 suppressing agents for a minimum of 10 days prior to starting lapatinibXx_NEWLINE_xXInclusion Criteria (TNBC Cohort Only):\n\n          -  Women ?18 years of age\n\n          -  Pathologically documented diagnosis of TNBC that is metastatic or locally advanced and\n             unresectable\n\n          -  Adequate hepatic function and coagulation profile\n\n          -  Negative HIV, HBV and HCV\n\n        Inclusion Criteria (HCC Cohort Only):\n\n          -  Men or Women ?18 years of age\n\n          -  Histological or cytological confirmed diagnosis of HCC with Barcelona Clinic Liver\n             Cancer Stage B or C who cannot benefit from resection, local ablation, or\n             chemoembolization\n\n          -  ECOG performance status of 0 or 1\n\n          -  Has at least 1 measurable lesion based on irRECIST 1.1.\n\n          -  Negative HIV tests\n\n        Inclusion Criteria (Either Cohort):\n\n          -  subject agrees to undergo a pre-treatment and an on-treatment biopsy of the tumor\n\n          -  Completion of all previous therapy for the treatment of cancer ?3 weeks before the\n             start of study drug\n\n          -  All acute toxic effects of any prior antitumor therapy resolved to Grade ?1 before the\n             start of study drug\n\n          -  Adequate bone marrow and renal function\n\n          -  Life expectancy of ?3 months\n\n        Exclusion Criteria (Either Cohort):\n\n          -  Pregnant or breastfeeding\n\n          -  History of another malignancy except for the following: adequately treated local basal\n             cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately\n             treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2\n             cancers currently in complete remission; or any other cancer that has been in complete\n             remission for ?2 years.\n\n          -  Gastrointestinal disease that may interfere with drug absorption or with\n             interpretation of GI AEs.\n\n          -  Known symptomatic brain metastases requiring ?10 mg/day of prednisolone (or its\n             equivalent).\n\n          -  Significant cardiovascular disease within 6 months prior to start of study drug\n\n          -  Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis or\n             requirement for systemic anticoagulation with unfractionated heparin,\n             low-molecular-weight heparin or heparin fractions, or oral anticoagulants.\n\n          -  Evidence of an ongoing systemic bacterial, fungal, or viral infection\n\n          -  Has received a live vaccine within 30 days of planned start of study drug\n\n          -  Major surgery within 4 weeks before the start of study drug\n\n          -  Prior solid organ or bone marrow progenitor cell transplantation\n\n          -  Prior therapy with any known inhibitor of MNK1 or MNK2\n\n          -  Prior high dose chemotherapy requiring stem cell rescue\n\n          -  History of or active autoimmune disorders or other conditions that might impair or\n             compromise the immune system\n\n          -  Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids\n\n          -  Use of a strong inhibitor or inducer of cytochrome P450 (CYP)3A4 within 7 days prior\n             to the start of study drug or expected requirement for use of a strong CYP3A4\n             inhibitor or inducer during study participation\n\n          -  Need for proton pump inhibitors and histamine H2 blockers\n\n          -  Previously received investigational product in a clinical trial within 30 days or\n             within 5 elimination half lives (whichever is longer) prior to the start of study\n             drug, or is planning to take part in another clinical trial while participating in\n             this study\n\n          -  HCC Cohort Only: Portal vein invasion at the main portal (Vp4), inferior vena cava, or\n             cardiac involvement of HCC based on imaging.Xx_NEWLINE_xXAgree not to try to become pregnant during the study and for 28 days after the final study drug administrationXx_NEWLINE_xXFemale subject must agree not to breastfeed at screening and throughout the study period, and for 28 days after the final study drug administration.Xx_NEWLINE_xXFemale subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.Xx_NEWLINE_xXMale subject must not donate sperm starting at screening and throughout the study period, and for 90 days after the final study drug administration.Xx_NEWLINE_xXSubject has received treatment with any other agent with antitumor activity including chemotherapy, radiotherapy, or immunotherapy within 14 days as well as EGFR tyrosine kinase inhibitor within 6 days prior to first dose of study drug.Xx_NEWLINE_xXSubject has any of the following within 14 days prior to the first dose of study drug:Xx_NEWLINE_xXSubject has received the following within 14 days prior to the first dose of study drug:Xx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must satisfy the following criteria to be enrolled in the study:\n\n          1. Subject received at least 3 prior anti-myeloma regimens including a proteasome\n             inhibitor (PI) and an immunomodulatory agent or is double-refractory to a PI and an\n             immunomodulatory agent.\n\n               -  Induction, bone marrow transplant with or without maintenance therapy is\n                  considered one regimen.\n\n               -  Refractory is defined as disease that is nonresponsive on therapy, or progresses\n                  within 60 days of last therapy. Nonresponsive disease is defined as either\n                  failure to achieve minimal response or development of progressive disease while\n                  on therapy.\n\n               -  For subjects who received more than 1 regimen containing a PI their disease must\n                  be refractory to the most recent PI containing regimen.\n\n               -  For subjects who received more than 1 regimen containing a immunomodulatory agent\n                  their disease must be refractory to the most recent immunomodulatory agent\n                  containing regimen.\n\n          2. All subjects must have failed Daratumumab (DARA) either as a single agent or in\n             combination on last Multiple myeloma (MM) therapy. Failure is defined as disease\n             progression(PD) on DARA either as a single agent or in combination.\n\n          3. Subject has measurable disease defined as:\n\n               1. M-protein (serum protein electrophoresis (sPEP) or urine protein electrophoresis\n                  (uPEP): sPEP ? 0.5 g/dL or uPEP ? 200 mg/24 hours) and/or\n\n               2. Light chain MM without measurable disease in the serum or the urine: serum\n                  immunoglobulin free light chain ?10 mg/dL and abnormal serum immunoglobulin kappa\n                  lambda free light chain ratio\n\n          4. Subject achieved a response (minimal response [MR] or better) to at least 1 prior\n             treatment regimen.\n\n          5. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 2\n             or less.\n\n          6. Subject's toxicities resulting from previous therapy (including peripheral neuropathy)\n             have resolved or stabilized to ? Grade 1.\n\n          7. Subject is at least 18 years of age the time of signing the informed consent form\n             (ICF).\n\n          8. Subject must understand and voluntarily sign an ICF prior to any study-related\n             assessments/procedures being conducted.\n\n          9. Subject is willing and able to adhere to the study visit schedule and other protocol\n             requirements.\n\n         10. Females of childbearing potential (FCBP) must:\n\n             a. Have 2 negative pregnancy tests as verified by the investigator prior to starting\n             study treatment. This applies even if the subject practices true abstinence from\n             heterosexual contact.\n\n             i. Negative serum pregnancy test at screening ii. Negative serum or urine pregnancy\n             test (investigator's discretion) within 72 hours prior to starting study treatment\n             (Cycle 1, Day 1), and before beginning each subsequent cycle of treatment, and after\n             end of study treatment.\n\n             b. Either practice true abstinence from heterosexual contact (which must be reviewed\n             on a monthly basis and source documented) or agree to use, and be able to comply with,\n             effective contraception without interruption (eg, oral, inject able, or implantable\n             hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive\n             with spermicide; true abstinence; or vasectomized partner), 28 days prior to starting\n             study treatment, during the study therapy (including dose interruptions), and for at\n             least 90 days after discontinuation of study treatment.\n\n             c. Agree to abstain from breastfeeding during study participation and for at least 90\n             days after the last dose of Daratumumab (DARA) or Durvalumab (DURVA), whichever is\n             later.\n\n             d. Refrain from egg cell donation for at least 90 days after the final dose of DURVA\n             or DARA, whichever is later.\n\n         11. Male subjects must:\n\n               1. Either practice true abstinence (which must be reviewed on a monthly basis) or\n                  agree to use a condom during sexual contact with a pregnant female or a female of\n                  childbearing potential while participating in the study, during dose\n                  interruptions and for at least 90 days following study treatment discontinuation,\n                  even if he has undergone a successful vasectomy.\n\n               2. Refrain from sperm donation for at least 90 days after the final dose of DURVA or\n                  DARA, whichever is later.\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment:\n\n          1. Subject has had prior exposure to anti-CTLA-4, anti-PD-1 (Programmed cell death-1),\n             anti-PD-L1 (Programmed death-ligand 1) Monoclonal antibody (mAbs), or cancer vaccines\n\n          2. Subject has received autologous stem cell transplantation (ASCT) within 12 weeks\n             before the date of randomization.\n\n          3. History of organ or allogeneic stem cell transplantation\n\n          4. Subject received any of the following within the last 14 days of initiating study\n             treatment:\n\n               1. Plasmapheresis\n\n               2. Major surgery (as defined by the investigator)\n\n               3. Radiation therapy other than local therapy for myeloma associated bone lesions\n\n               4. Use of any systemic anti-myeloma drug therapy (except for DARA either alone or in\n                  combination with other agents given with it)\n\n          5. Subject received prior treatment with a monoclonal antibody within 5 half-lives of\n             initiating study treatment, other than DARA.\n\n          6. Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for\n             cancer treatment. Note: Concurrent use of hormones for noncancer-related conditions\n             (eg, insulin for diabetes and hormone replacement therapy) is acceptable.\n\n          7. Subject has any of the following laboratory abnormalities:\n\n               1. Absolute neutrophil count (ANC) < 1,000/µL\n\n               2. Platelet count: < 75,000/µL (it is not permissible to transfuse a subject to\n                  reach this level)\n\n               3. Hemoglobin < 8 g/dL (< 4.9 mmol/L) (it is not permissible to transfuse a subject\n                  to reach this level)\n\n               4. Creatinine clearance (CrCl) < 45 mL/min (calculated using the Cockcroft-Gault\n                  formula or directly calculated from the 24-hour urine collection method)\n\n               5. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)\n\n               6. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 ×\n                  upper limit of normal (ULN)\n\n               7. Serum total bilirubin > 1.5 × upper limit of normal (ULN) or > 3.0 mg/dL for\n                  subjects with documented Gilbert's syndrome\n\n          8. Subject has clinical evidence of central nervous system (CNS) or pulmonary\n             leukostasis, disseminated intravascular coagulation, or CNS MM\n\n          9. Subject has known chronic obstructive pulmonary disease (COPD) with a forced\n             expiratory volume in 1 second (FEV1) < 50% of predicted normal. Note that forced\n             expiratory testing (FEV1) is required for subjects suspected of having COPD and\n             subjects must be excluded if FEV1 is < 50% of predicted normal.\n\n         10. Subject has known moderate or severe persistent asthma within the past 2 years or\n             uncontrolled asthma of any classification. Note that subjects who currently have\n             controlled intermittent asthma or controlled mild persistent asthma are allowed to\n             participate in the study.\n\n         11. Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome\n             (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes),\n             or amyloidosis\n\n         12. Subject has nonsecretory MM\n\n         13. Subject has known allergy or hypersensitivity to study drug formulations\n\n         14. Subject has active or prior documented autoimmune or inflammatory disorders (including\n             inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis, celiac\n             disease, irritable bowel disease, or other serious gastrointestinal chronic conditions\n             associated with diarrhea; systemic lupus erythematosus; Wegener syndrome; myasthenia\n             gravis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis, etc) within the\n             past 3 years prior to the start of treatment. The following are exceptions to this\n             criterion:\n\n               1. Subjects with vitiligo or alopecia.\n\n               2. Subjects with hypothyroidism (eg, following Hashimoto's disease) stable on\n                  hormone replacement.\n\n               3. Psoriasis not requiring systemic treatment.\n\n         15. Subject has history of primary immunodeficiency\n\n         16. Subject is positive for human immunodeficiency virus (HIV-1), chronic or active\n             hepatitis B or active hepatitis A or C.\n\n         17. Subject has received live, attenuated vaccine within 30 days prior to the first dose\n             of DURVA (NOTE: Subjects, if enrolled, should not receive live vaccine during the\n             study and through 30 days after the last dose of DURVA)\n\n         18. Subject is currently using or has used immunosuppressive medication within 14 days\n             prior to the first study dose of study treatment. The following are exceptions to this\n             criterion:\n\n               1. Intranasal, topical, inhaled, or local steroid injections (eg, intra-articular\n                  injection).\n\n               2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of\n                  prednisone or equivalent.\n\n               3. Steroids as premedication for hypersensitivity reactions (eg, infusion-related\n                  reactions, computed tomography [CT] scan premedication).\n\n         19. Subject has any one of the following:\n\n               1. Clinically significant abnormal Electrocardiogram (ECG) finding at screening\n\n               2. Congestive heart failure (New York Heart Association Class III or IV)\n\n               3. Myocardial infarction within 12 months prior to starting study treatment\n\n               4. Unstable or poorly controlled angina pectoris, including Prinzmetal variant\n                  angina pectoris\n\n         20. Subject has prior history of malignancies, other than MM, unless the subject has been\n             free of the disease for ? 5 years with the exception of the following noninvasive\n             malignancies:\n\n               1. Basal cell carcinoma of the skin\n\n               2. Squamous cell carcinoma of the skin\n\n               3. Carcinoma in situ of the cervix\n\n               4. Carcinoma in situ of the breast\n\n               5. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM\n                  [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is\n                  curative\n\n         21. Subject is a female who is pregnant, nursing, or breastfeeding, or who intends to\n             become pregnant during the participation in the study.\n\n         22. Subject has any significant medical condition, laboratory abnormality, or psychiatric\n             illness that would prevent the subject from participating in the study\n\n         23. Subject has any condition including the presence of laboratory abnormalities, which\n             places the subject at unacceptable risk if he/she were to participate in the study\n\n         24. Subject has any condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXHas received systemic anti-cancer therapy within the 14 days prior to randomizationXx_NEWLINE_xXPatients with steroid refractory graft versus host disease (SRGvHD). SRGvHD is defined as progression (=increase in overall grade) after 5 days on ?2mg/kg methylprednisolone or equivalent OR no improvement (no decrease in overall grade) after 10 days on ? 2mg/kg methylprednisolone or equivalent. If patients are receiving steroids for GvHD prophylaxis as per center standard, progression after 5 days and no response after 10 days after doubling the steroid dose will be regarded as steroid refractory.Xx_NEWLINE_xXUse of investigational drug, other than the study medications specified by the protocol, within 30 days of transplantationXx_NEWLINE_xXReceipt of investigational drugs within 14 days before D1 of alisertibXx_NEWLINE_xXPatient must start maintenance therapy at least 14 days after the last administered induction chemotherapy but no later than 30 daysXx_NEWLINE_xXFor Post-allo Part B: Treatment must begin at least 60 days, but no more than 100 days post-transplant.Xx_NEWLINE_xXReceived any of the following within the specified time frame prior to the first administration of study drug:Xx_NEWLINE_xXInclusion Criteria:\n\n        Part 1 and Part 2\n\n          1. Is male or female aged 18 years or older at the time of consent.\n\n          2. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14\n             days before enrollment.\n\n          3. Has adequate organ and hematologic function as evidenced by the following laboratory\n             values within 14 days before enrollment:\n\n               -  Absolute neutrophil count (ANC) ?1.5x10^9/L.\n\n               -  Platelet count ?100x10^9/L.\n\n               -  Hemoglobin ?9 g/dL (Transfusions are allowed to reach this hemoglobin level).\n\n               -  Serum creatinine ?1.5 times the upper limit of the normal range (ULN) or\n                  creatinine clearance ?50 mL/min either as estimated by the Cockcroft-Gault\n                  equation or based on urine collection (12 or 24 hours).\n\n               -  Total bilirubin ?1.5×ULN.\n\n               -  Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ?2.5×ULN.\n\n          4. Female participants who:\n\n               -  Are postmenopausal for at least 1 year before the screening visit, OR\n\n               -  Are surgically sterile, OR\n\n               -  If they are of childbearing potential, agree to practice 1 highly effective\n                  method and 1 additional effective (barrier) method of contraception at the same\n                  time, from the time of signing the informed consent form through 30 days after\n                  the last dose of study drug (with the exception of those participants assigned to\n                  TAK-659, for whom the duration required is 180 days), or for as long as mandated\n                  by local labeling for docetaxel and paclitaxel, OR\n\n               -  Agree to practice true abstinence, when this is in line with the preferred and\n                  usual lifestyle of the participant, from the time of signing the informed consent\n                  form through 30 days after the last dose of study drug (with the exception of\n                  those participants assigned to TAK-659, for whom the duration required is 180\n                  days), or for as long as mandated by local labeling for docetaxel and paclitaxel.\n                  (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation\n                  methods], withdrawal, spermicides only, and lactational amenorrhea are not\n                  acceptable methods of contraception. Female and male condoms should not be used\n                  together.)\n\n             Male participants, even if surgically sterilized (ie, status postvasectomy), who:\n\n               -  Agree to practice effective barrier contraception during the entire study\n                  treatment period and through 120 days after the last dose of study drug (with the\n                  exception of those participants assigned to TAK-659, for whom the duration\n                  required is 180 days), or for as long as mandated by local labeling for docetaxel\n                  and paclitaxel, OR\n\n               -  Agree to practice true abstinence, when this is in line with the preferred and\n                  usual lifestyle of the participant during the entire study treatment period and\n                  through 120 days after the last dose of study drug (with the exception of those\n                  participants assigned to TAK-659, for whom the duration required is 180 days) or\n                  for as long as mandated by local labeling for docetaxel and paclitaxel. (Periodic\n                  abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the\n                  female partner] and withdrawal are not acceptable methods of contraception.)\n\n          5. Voluntary written consent must be given before performance of any study-related\n             procedure not part of standard medical care, with the understanding that consent may\n             be withdrawn by the participant at any time without prejudice to future medical care.\n\n          6. Has suitable venous access for the study-required blood sampling (ie, pharmacokinetic\n             (PK) sampling, circulating tumor deoxyribonucleic acid [DNA]).\n\n        Part 1 only\n\n          1. Has a histologically confirmed diagnosis of advanced solid tumor, including but not\n             limited to gastric or gastroesophageal junction adenocarcinoma.\n\n          2. Has radiographically or clinically evaluable disease. Measurable disease as defined by\n             Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 is not required.\n\n          3. Is relapsed or refractory with no effective therapeutic options available.\n\n        Part 2 only\n\n          1. Has a histologically confirmed diagnosis of metastatic or locally advanced\n             adenocarcinoma of the stomach or gastroesophageal junction (Stage IIIb or IV according\n             to International Union Against Cancer [UICC] tumor, node, metastases [TNM]\n             classification, 7th edition).\n\n          2. Has at least 1 measurable tumor lesion per RECIST Version 1.1 by radiographic\n             techniques (computed tomography [CT] or magnetic resonance imaging [MRI]).\n\n          3. Has receipt of 1 prior systemic chemotherapy regimen for advanced or metastatic\n             adenocarcinoma of the stomach or gastroesophageal junction with documented progressive\n             disease (PD).\n\n          4. Has archived or fresh tumor biopsy samples obtained during screening sufficient for\n             Epstein-Barr virus (EBV) testing and genotyping.\n\n        Exclusion Criteria:\n\n        Part 1 and Part 2\n\n          1. Has received prior systemic anticancer therapies or other investigational agents\n             within 2 weeks before the first administration of study drug or has failed to recover\n             from the adverse drug effects of prior therapies (to ?Grade 1 or to a level meeting\n             inclusion criteria). For prior therapies with a half-life longer than 3 days, the\n             interval must equal minimally 28 days before the first administration of study drug\n             and the participant must have documented PD.\n\n          2. Has radiotherapy within 14 days before enrollment.\n\n          3. Has fasting glucose ?130 mg/dL. Poorly controlled diabetes mellitus (glycosylated\n             hemoglobin [HbA1c] >7.0%). Participants with a history of transient glucose\n             intolerance due to corticosteroid administration are allowed.\n\n          4. Has received strong cytochrome P-450 (CYP) 3A4 inducers/inhibitors within 7 days\n             before the first administration of study drug or has conditions that require the\n             concomitant use of CYP3A4 inducers/inhibitors during the course of the study.\n\n          5. For TAK-659 (Cohort A) only: Is receiving treatment with medications that are known to\n             be inhibitors or inducers of P-glycoprotein (P-gp). Baseline lipase >ULN. Participants\n             not fulfilling these exclusion criteria can be enrolled in other cohorts (Part 1\n             only).\n\n          6. Has taken proton pump inhibitors within 7 days before the first administration of\n             study drug or has conditions that require the concomitant use of proton pump\n             inhibitors during the course of the study.\n\n          7. Has signs of peripheral neuropathy ? National Cancer Institute Common Terminology\n             Criteria for Adverse Events (NCI CTCAE) Grade 2.\n\n          8. Has symptomatic brain metastases or brain metastases with a stable neurologic status\n             for <2 weeks after completion of the definitive therapy and steroids.\n\n          9. Has systemic infection requiring intravenous (IV) antibiotic therapy or other serious\n             infection within 14 days before the first dose of study drug.\n\n         10. Has known or suspected human immunodeficiency virus (HIV) positive or hepatitis B\n             surface antigen-positive status, or known or suspected active hepatitis C infection.\n             Testing for these agents is not required in the absence of clinical findings or\n             suspicion.\n\n         11. Has known gastrointestinal (GI) disease or GI procedure that could interfere with the\n             oral absorption or tolerability of orally administered study drug, including\n             difficulty swallowing tablets; diarrhea >Grade 1 despite supportive therapy; or prior\n             total gastrectomy.\n\n         12. Has clinically significant comorbidities, such as uncontrolled pulmonary disease,\n             known impaired cardiac function or clinically significant cardiac disease, active\n             central nervous system disease, or any other condition that could compromise the\n             participant's participation in the study.\n\n             • Known impaired cardiac function or clinically significant cardiac disease includes:\n             evidence of currently uncontrolled cardiovascular conditions (including arrhythmias,\n             angina, pulmonary hypertension, acute ischemia or active conduction system\n             abnormalities); current history of New York Heart Association Class III or IV heart\n             failure; acute myocardial infarction within 6 months before starting study drug;\n             baseline QT interval corrected for heart rate (QTc) ?Grade 1 according to NCI CTCAE\n             Version 4.03 criteria; or abnormalities on baseline 12-lead ECG that are considered\n             clinically significant per the investigator.\n\n         13. Female participants who are lactating and breastfeeding or have a positive serum\n             pregnancy test during the screening period or a positive urine pregnancy test on Day 1\n             before the first dose of study drug.\n\n         14. Participants with bilirubin >ULN, or AST and/or ALT >1.5 X ULN concomitant with\n             alkaline phosphatase >2.5 X ULN cannot be allocated to Cohort D (MLN1117+docetaxel) in\n             Part 1 and are not eligible for Part 2 if they are also EBV negative.\n\n        Part 2 only\n\n        1. Has prior treatment with any of the following:\n\n          -  An Aurora A-targeted agent (not eligible for randomization in Cohorts B, C, or D, but\n             eligible for Cohort A if EBV positive).\n\n          -  A docetaxel- or paclitaxel-containing chemotherapy regimen (not eligible for\n             randomization in Cohorts B, C, or D, but eligible for Cohort A if EBV positive).\n\n          -  A spleen tyrosine kinase (SYK) inhibitor (MLN1117+TAK-659 arm only).\n\n          -  A phosphoinositide 3-kinase (PI3K) or serine/threonine kinase, also known as protein\n             kinase B or PKB (AKT) inhibitor.Xx_NEWLINE_xXPatients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment.Xx_NEWLINE_xXAgree not to try to become pregnant during the study and for 45 days after the final study drug administrationXx_NEWLINE_xXSubject received an EGFR TKI for at least 6 months and progressed on this therapy within the past 28 days.Xx_NEWLINE_xXSubject has not had any intervening anticancer treatment subsequent to the EGFR TKI with the exception of radiotherapy which is allowed if it occurred at least 14 days prior to the first dose of study drug.Xx_NEWLINE_xXAny stereotactic radiosurgery (SRS) was completed at least 1 week prior to the first dose of study drug.Xx_NEWLINE_xXSubject has history of gastrointestinal ulcer within 28 days prior to the first dose of study drug.Xx_NEWLINE_xXLVEF < 40% as determined by echocardiogram performed at screening or within 90 days prior to C1D1Xx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomibXx_NEWLINE_xXSubjects who are current smokers or users of other tobacco products or have quit <90 days before first dose of study drugXx_NEWLINE_xXAbGn-168H (neihulizumab) therapy can begin not more than 14 days after diagnosis of aGvHDXx_NEWLINE_xXTreatment with other investigational agents within the prior 7 days prior to the 1st dose of AbGn-168H (neihulizumab)Xx_NEWLINE_xXPrior cancer therapy or other investigational therapy within 2 weeks before the first administration of study drug or failed to recover from the reversible effects of prior anticancer therapies. For prior therapies with a half-life longer than 3 days, the interval must be at least 28 days before the first administration of study drug, and the participant must have documented progressive disease.Xx_NEWLINE_xXHas taken proton pump inhibitors within 7 days before the first administration of study drug.Xx_NEWLINE_xXAdequate liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to starting study treatment:Xx_NEWLINE_xXUse of an investigational drug within 30 days prior to screening.Xx_NEWLINE_xXRecent infection requiring intravenous (IV) systemic treatment that was completed ?14 days before the first dose of study drug.Xx_NEWLINE_xXCurrent use (within 10 days of day 1) of megestrol acetate.Xx_NEWLINE_xXMonoclonal antibody therapy < 30 days from study enrollmentXx_NEWLINE_xXSubjects who will be or are currently being treated with high dose estrogen (high dose is defined as >0.625mg daily as conjugated estrogens or equivalent) within 7 days prior to study enrollmentXx_NEWLINE_xXLast dose of systemic anti-neoplastic therapy > 21 days prior to first RO6927005 infusionXx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708 (ixazomib citrate)Xx_NEWLINE_xXUse of any investigational drugs, biologics, or devices within 28 days prior to study enrollmentXx_NEWLINE_xXFor those patients who had a biliary stent inserted, 2 stable bilirubin readings within 48 to 72 hours of each other taken at least 5 days and not more than 14 days post-stenting must be obtained. In addition, there should be no complications (eg, infection) present and bilirubin levels should have stabilized (2 readings with total bilirubin within 20% of each other) before administering first treatment.Xx_NEWLINE_xXUse of any anti-cancer drug therapy within 14 days prior to Baseline (within 28 days for monoclonal antibodies [eg anti-CD38]).Xx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708Xx_NEWLINE_xXFrench subjects: the French subject has participated in any study using an investigational drug during the previous 30 daysXx_NEWLINE_xXConcurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollmentXx_NEWLINE_xXAcute treatment for an infection (other than oral thrush or genital herpes) or other serious medical illness within 14 days of enrollmentXx_NEWLINE_xXPrior systemic therapy within 14 days of initiating protocol treatmentXx_NEWLINE_xXReceipt of any investigational agents within 14 days before the first dose of ibrutinibXx_NEWLINE_xXDiagnostic of cholangiocarcinoma made more than 45 days prior to randomizationXx_NEWLINE_xXParticipated in another drug study within 90 days before this oneXx_NEWLINE_xXAnti-neoplastic treatment less than 14 days prior to enrollment, with the exceptions of hydroxyurea or, in the case of a patient with primary refractory AML, prior induction chemotherapyXx_NEWLINE_xXBaseline MRI must be performed after subject signs informed consent form (ICF), within 17 days of Day 1, & on steroid dosage that has been stable or decreasing for at least 5 daysXx_NEWLINE_xX14 days from last dose of bevacizumabXx_NEWLINE_xXSubjects whose primary physicians determine that anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) cannot be safely discontinued from 2 days prior to the injection to 28 days following the injection are excluded from this studyXx_NEWLINE_xXRadiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of MLN9708Xx_NEWLINE_xXInvestigational agents within 28 days of dosing; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the principal investigatorXx_NEWLINE_xXInclusion Criteria:\n\n        Registration: Patients having both diffuse and follicular architectural elements will be\n        considered eligible if the histology is predominantly follicular (? 50% of the\n        cross-sectional area), and there is no evidence of transformation to a large cell\n        histology.\n\n          -  Biopsy-proven diagnosis of Grade 1 or 2 follicular non-Hodgkin's lymphoma with no\n             evidence of transformation to large cell histology.\n\n          -  Meet criteria for Low Tumor Burden:\n\n               -  No nodal or extra nodal mass ? 7 centimeter (cm)\n\n               -  <3 nodal masses >3 cm in diameter\n\n               -  No systemic symptoms or B symptoms\n\n               -  No splenomegaly >16 cm by CT scan\n\n               -  No risk of compression of a vital organ.\n\n               -  No leukemic phase with >5000/mm³ circulating lymphocytes.\n\n          -  No cytopenias defined as:\n\n               -  Platelets <100,000/mm³\n\n               -  Hemoglobin (Hgb) <10 g/dL\n\n               -  Absolute Neutrophil Count (ANC) <1500/mm³\n\n          -  Must have Stage III or Stage IV disease.\n\n          -  Baseline measurements/evaluations obtained within 6 weeks of registration. Patient\n             must have at least one objective measurable disease parameter.\n\n          -  Age ? 18 years.\n\n          -  Eastern Oncology Cooperative Group Performance Status 0-1.\n\n          -  Must not have received investigational agents within 30 days of registration.\n\n          -  Signed Institutional Review Board (IRB)-approved informed consent.\n\n          -  Willing to provide blood samples for research purposes.\n\n          -  Women must not be pregnant or breastfeeding.\n\n          -  Women of childbearing potential and sexually active males must use an accepted and\n             effective method of contraception.\n\n          -  No prior chemotherapy, radiotherapy or immunotherapy for lymphoma.\n\n          -  No prior treatment with cytotoxic drugs or rituximab for a previous cancer or another\n             condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody.\n\n          -  No prior use of any monoclonal antibody within 3 months of randomization.\n\n          -  No history of severe allergic/anaphylactic reactions to humanized/murine monoclonal\n             antibodies or known sensitivity/allergy to murine products.\n\n          -  No history of prior malignancy except for adequately treated basal cell or squamous\n             cell skin cancer, in situ cervical cancer, or other cancer for which the patient has\n             been disease-free for at least 2 years and did not require treatment with cytotoxic\n             drugs or rituximab.\n\n          -  No major surgery within 4 weeks prior to randomization, other than for diagnosis.\n\n          -  Must be Human Immunodeficiency Virus (HIV) negative.\n\n          -  Have adequate organ function without growth factor and/or transfusion support within ?\n             2 weeks prior to registration:\n\n               -  ANC ? 1500/mm³\n\n               -  Hgb ? 10 g/dL\n\n               -  Platelets ? 100,000/mm³\n\n               -  Serum Creatinine ? 2x Upper Limit Normal (ULN)\n\n               -  Total Bilirubin ? 2x ULN\n\n               -  AST (aspartate aminotransferase)/ALT (alanine aminotransferase) ? 5x ULN\n\n               -  PTT (Partial Thromboplastin Time) or aPTT (activated Partial Thromboplastin Time)\n                  >1.5x the ULN in the absence of a lupus anticoagulant\n\n               -  INR (International Normalized Ratio) >1.5x the ULN in the absence of therapeutic\n                  anticoagulation\n\n          -  No active, uncontrolled infections (afebrile for ? 48 hours off antibiotics).\n\n          -  Must not receive immunization with attenuated live vaccines within 28 days prior to\n             registration or during the study period.\n\n          -  Must be tested for hepatitis B surface antigen (HBsAg) and total hepatitis B core\n             antibody (anti-HBc) within 2 weeks of registration. Patients who are chronic carriers\n             of HBsAg and anti-HBc are excluded.\n\n          -  Must be tested for hepatitis C antibody within 2 week of registration. If this test is\n             positive, patients are excluded unless a hepatitis C virus ribonucleic acid (HCV RNA)\n             is negative.\n\n          -  No evidence of significant, uncontrolled concomitant diseases that could affect\n             compliance with the protocol or interpretation of results, including significant\n             cardiovascular disease (i.e., severe arrhythmia, myocardial infarction within the\n             previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease.Xx_NEWLINE_xXBiologic (anti-neoplastic agent) or metronomic non-myelosuppressive chemotherapy: at least 7 days must have elapsed since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occurXx_NEWLINE_xXReceived investigational drug within 30 days prior to study dosing. Patients may participate in non-interventional or observational clinical studies, including the 10PLK13 PROCLAIM registry study.Xx_NEWLINE_xXHistory/physical examination within 30 days prior to registrationXx_NEWLINE_xXThe subject has received radiation therapy:\r\n* To the thoracic cavity or gastrointestinal tract within 3 months of the first dose of study treatment\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatmentXx_NEWLINE_xXPatient has received other investigational drugs or chemotherapy within 21 days or approved anti-myeloma therapy within 14 days.Xx_NEWLINE_xXInclusion Criteria:\n\n        3.1.1 Histologically-proven, invasive primary squamous, basaloid, or cloacogenic carcinoma\n        of the anal canal; 3.1.2 AJCC 2009 TN Stage: T1N1-N3, T2(< 4cm)N1-N3, T2(> 4cm)N0,T3N0-3,\n        T4N0-3;based upon the following minimum diagnostic workup: 3.1.2.1 History/physical\n        examination within 14 days prior to registration; 3.1.2.2 Within 42 days prior to\n        registration, the patient must have an anal examination by any of the following:\n        colonoscopy, sigmoidoscopy, or rigid proctoscopy, with documentation of primary anal lesion\n        size, distance from anal verge.\n\n        3.1.3 Groin examination within 42 days prior to registration with documentation of any\n        groin adenopathy and lymphadenopathy (location: right vs. left; medial vs. lateral; mobile\n        vs. fixed; and size); 3.1.4 X-ray (PA and lateral), CT scan, or PET/CT scan of the chest\n        within 42 days prior to registration; 3.1.5 CT scan, MRI, or PET/CT of the abdomen and\n        pelvis within 42 days prior to registration; 3.1.6 Zubrod Performance Status 0-1; 3.1.7 Age\n        ? 18; 3.1.8 Laboratory data obtained ? 14 days prior to registration on study, with\n        adequate bone marrow, hepatic and renal function defined as follows:\n\n          -  Absolute neutrophil count (ANC) ? 1,500 cells/mm3;\n\n          -  Platelets ? 100,000 cells/mm3;\n\n          -  Hemoglobin ? 8.0 g/dl (Note: The use of transfusion or other intervention to achieve\n             Hgb ? 8.0 g/dl is acceptable.);\n\n          -  Serum creatinine ? 1.5 mg/dl;\n\n          -  Bilirubin < 1.4mg/dl;\n\n          -  ALT/AST < 3 x ULN;\n\n          -  Negative serum pregnancy test for women of child-bearing potential; 3.1.9 Women of\n             childbearing potential and male participants must agree to use a 2 forms of medically\n             effective means of birth control (such as a condom and spermicide) throughout their\n             participation in the treatment phase of the study and for 90 days post last dose of\n             study drug.\n\n        3.1.10 Patients must sign a study-specific informed consent prior to study entry.\n\n        3.1.11 Patients with a history of clinically significant pulmonary disease must have PFTs\n        demonstrating a DLCO ? 40%. This testing is considered standard of care prior to mitomycin,\n        5-FU and radiation.\n\n        3.1.12 Patients with a history of clinically significant cardiac disease must have a LVEF ?\n        30% by ECHO. (MUGA scan may also be used to determine LVEF) This testing is considered\n        standard of care prior to mitomycin, 5-FU and radiation.\n\n        3.1.13 Patients must be able to swallow pills.\n\n        Exclusion Criteria:\n\n        3.2.1 Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free\n        for a minimum of 2 years; 3.2.2 Prior systemic chemotherapy for anal cancer; 3.2.3 Prior\n        allergic reaction to the study drugs involved in this protocol. 3.2.4 Prior radiotherapy to\n        the pelvis that would result in overlap of radiation therapy fields; 3.2.5 Severe, active\n        co-morbidity, defined as follows: 3.2.5.1 Patients with uncontrolled intercurrent illness\n        including, but not limited to ongoing or active infection, symptomatic congestive heart\n        failure, unstable angina pectoris and cardiac arrhythmia are ineligible. Furthermore,\n        patients with unstable angina and/or congestive heart failure requiring hospitalization\n        within the past 6 months are ineligible; 3.2.5.2 Patients with active infection requiring\n        systemic therapy (oral or IV) or those currently receiving antibiotics that cannot\n        discontinue prior to dosing are ineligible.\n\n        3.2.5.3 Transmural myocardial infarction within the last 6 months; 3.2.5.4 Acute bacterial\n        or fungal infection requiring intravenous antibiotics at the time of registration; 3.2.5.5\n        Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring\n        hospitalization or precluding study therapy at the time of registration; 3.2.5.6 Hepatic\n        insufficiency resulting in clinical jaundice and/or coagulation defects; 3.2.6 Patients\n        known to be seropositive for HIV and/or active hepatitis, even if liver function studies\n        are in the eligible range.\n\n        3.2.7 Other immunocompromised status (e.g., organ transplant or chronic glucocorticoid\n        use).If patient has diagnosis of immunodeficiency, is dependent on or has received systemic\n        steroids therapy or any form of immunosuppressive therapy within 7 days prior to the first\n        dose of ADXS11-001 they are ineligible. Topical corticosteroid or occasional inhaled\n        corticosteroids are allowed.\n\n        3.2.8 Women who are pregnant or lactating are ineligible because the treatment involved in\n        this study may be significantly teratogenic and there is the potential for transmission of\n        listeria to the infant.\n\n        3.2.9 Patients allergic to or with a sensitivity to penicillin, ampicillin,\n        trimethoprim-sulfa and quinolones (including history of rash or anaphylaxis).\n\n        3.2.10 Patients allergic to naproxen. 3.2.11 Patients receiving oral or IV antibiotics\n        3.2.12 Patients with a prior history of a splenectomy and/or sickle cell trait/disease\n        3.2.13 Patient has implanted medical device(s) that pose a high risk for colonization\n        and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves,\n        pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous\n        implant(s)). NOTE: More common devices and prosthetics which include arterial and venous\n        stents, dental and breast implants and venous access devices (e.g. Port-a-Cath or Mediport)\n        are permitted. Sponsor must be contacted prior to consenting any subject who has any other\n        device and/or implant. Site is required to submit to BrUOG ALL surgical implants patient\n        has ever had in their medical history and ALL surgeries regardless of link to this cancer\n        diagnosis.\n\n        3.2.14 Patients who are receiving or may receive future treatment with PI3K or TNF?\n        inhibitors. To be confirmed by treating medical oncologist in writing 3.2.15 Has undergone\n        a major surgery, including surgery for a new artificial implant and/or device, within 6\n        weeks prior to the initiation of ADXS11-001 treatment. NOTE: if patient underwent surgery >\n        6 weeks from start of ADSX11-001, all toxicities and/or complications must have recovered\n        to baseline or Grade 1 prior to the initiation of ADXS11-001 study therapy.\n\n        3.2.16 Patient not being willing to have new infusion line placed for each infusion of\n        ADXS11-001 as existing or newly placed central venous catheter or infusion ports are not\n        allowed to be used for ADXS11-001 administration. Must be confirmed as discussed with\n        patient and that they agreed.\n\n        3.2.17 Patient not willing to comply with requirement of central venous catheter or\n        infusion port must not be used for 72 hours following the completion of the ADXS11-001\n        infusion and the patient receives the first post-treatment dose of oral antibiotics. Must\n        be confirmed as discussed with patient and that they agreed.\n\n        3.2.18 Live vaccines within 30 days prior to the first dose of trial treatment and while\n        participating in the trial. Examples of live vaccines include, but are not limited to, the\n        following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid\n        (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus\n        vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live\n        attenuated vaccines and are not allowed. All recent vaccines (within 30 days) to be listed\n        on conmed log 3.2.19 Patient has a history of listeriosis or prior ADXS11-001 therapy.Xx_NEWLINE_xXInclusion Criteria:\n\n        • Cytomorphologically documented diagnosis of acute myeloid leukemia (AML). Acute\n        promyelocytic leukemia patients will be excluded (FAB M3). FAB classification, cytogenetics\n        and molecular markers (if applicable) must be available at registration.\n\n        Phase I Enrollment:\n\n          -  Must be in first or second complete remission, e.g., no evidence of active disease in\n             blood, bone marrow (<5% blasts), or other tissues.\n\n          -  For each remission, may have received no more than 2 cycles of induction treatment\n             (any type).\n\n          -  May have received no more than one course of consolidation for the current remission\n             prior to enrollment (any type)\n\n        Phase II Enrollment:\n\n          -  Must be in first complete remission, e.g., no evidence of active disease in blood,\n             bone marrow (<5% blasts), or other tissues.\n\n          -  May have received no more than 2 cycles of induction treatment (any type).\n\n        Enrollment in Either Phase:\n\n          -  Remission status must be documented by a bone marrow examination up to 28 days prior\n             to study registration.\n\n          -  Have recovered from induction and first consolidation (if applicable) therapy side\n             effects (or ?grade 1).\n\n          -  ?18 years of age and ?70 years of age.\n\n          -  ECOG performance status 0, 1, 2.\n\n          -  Have not received cytotoxic drug therapy within 21 days of registration.\n\n          -  Have not received hematopoietic colony stimulating growth factors within 14 days of\n             registration.\n\n          -  Have not received packed red blood cells or platelets within 7 days of registration.\n\n          -  Have not received investigational agents within 30 days of registration and will not\n             receive any investigational agents other than eltrombopag/placebo during study.\n\n          -  Signed IRB-approved informed consent.\n\n          -  Willing to provide blood samples for research purposes.\n\n          -  Adequate organ function obtained within 28 days prior to registration:\n\n               -  Absolute neutrophil count >1 x 10?/L\n\n               -  Platelet count >100 x 10?/L\n\n               -  Total direct serum bilirubin ?1.5x upper limit of normal (ULN)\n\n               -  ALT and AST ?3x ULN\n\n               -  BUN and serum creatinine <2x ULN\n\n               -  Albumin ?2.5 g/dL\n\n               -  PT and PTT 80-120% of institutional normal range\n\n          -  Women of childbearing potential must have a negative serum pregnancy test within 14\n             days of registration.\n\n          -  Not pregnant nor breast feeding.\n\n          -  Women of childbearing potential and sexually active males must use an accepted and\n             effective method of contraception.\n\n          -  Patients of known East Asian ancestry (Chinese, Japanese, Taiwanese, and Korean) are\n             excluded from protocol participation for safety and efficacy reasons.\n\n          -  Able to swallow and retain orally administered medication.\n\n          -  No clinically significant gastrointestinal abnormalities such as malabsorption\n             syndrome or major resection of the stomach or bowels.\n\n          -  No clinical evidence of hepatomegaly or splenomegaly.\n\n          -  No known risk for Torsades de Pointes. (Eltrombopag use has not been shown to be\n             associated with Torsades de Pointes.)\n\n          -  No active or unresolved infection and must be off all antibiotics for at least 7 days\n             prior to registration.\n\n          -  No current evidence of invasive fungal infection.\n\n          -  No known Hepatitis B, Hepatitis C active disease.\n\n          -  No known Human Immunodeficiency Virus (HIV) seropositivity. The risk for potential\n             toxicities secondary to HIV (e.g., increased risk for fatal opportunistic infection)\n             may confound the toxicity profile of eltrombopag.\n\n          -  Patients with a history of Central Nervous System (CNS) leukemia are eligible if there\n             is documentation of no current CNS involvement on cerebrospinal fluid (CSF)\n             examination (e.g., negative CSF by lumbar puncture) within 28 days of registration.\n\n          -  No prior or concomitant malignancy in the past 5 years which is currently active and\n             likely to interfere with the patient's treatment for AML or which is likely to\n             increase the patient's morbidity or mortality. No prior chemotherapy or radiation\n             therapy allowed (unless related to AML treatment).\n\n          -  No concurrent organ damage or medical problems that would prohibit therapy.Xx_NEWLINE_xXReceived systemic steroids within 30 days of study enrollmentXx_NEWLINE_xXPatients taking Metformin for any reason within 30 days of enrollment to the studyXx_NEWLINE_xXPatients must not have the following foods/ supplements at least 7 days prior to initiation of and during study treatment:Xx_NEWLINE_xXInitiation of a new drug therapy within the past 30 days prior to study commencementXx_NEWLINE_xXPatients who are not on a stable or decreasing steroid dose for the previous week prior to the first dose of study enrollmentXx_NEWLINE_xXPatient has received other investigational drugs with 14 days before enrollmentXx_NEWLINE_xXAny major operation must have occurred at least 28 days before study enrollmentXx_NEWLINE_xXRECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients must have received their last dose of known myelosuppressive anticancer therapy or immunotherapy at least 21 days prior to enrollment (42 days if prior nitrosourea)Xx_NEWLINE_xXRECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have had valproic acid within 28 days prior to enrollmentXx_NEWLINE_xXNeutrophils >= 1.5 K/microliter should be obtained with 28 days prior to randomizationXx_NEWLINE_xXPlatelets >= 100 K/microliter should be obtained with 28 days prior to randomizationXx_NEWLINE_xXCurrent enrollment in another interventional clinical study or used any investigational drug or device within the past 28 days preceding informed consent.Xx_NEWLINE_xXConcomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugsXx_NEWLINE_xXTreatment with chemotherapy or monoclonal antibody within 28 days prior to entering the studyXx_NEWLINE_xXThiazide therapy within 7 days from entering the studyXx_NEWLINE_xXEvidence of measurable disease based on imaging studies within 28 days before the first dose of study drugXx_NEWLINE_xXAntineoplastic therapy, radiotherapy, or any other investigational drug within 30 days prior to first study drug administrationXx_NEWLINE_xXPatient must be able to be treated with remestemcel-L within 4 days of study entry.Xx_NEWLINE_xXPatients must not previously have received the Prevnar 13 pneumococcal vaccination; NOTE: previous vaccination with Pneumovax (PCV23) is permitted but must have been at least 365 days prior to registrationXx_NEWLINE_xXConcurrent or prior use of immunosuppressive medication within 28 days;Xx_NEWLINE_xXThe patient has a caregiver for 28 days after dosing.Xx_NEWLINE_xXPatients receiving hormonal therapy (i.e. any dose of megestrol acetate [Megace], Proscar [finasteride], any herbal product known to decrease PSA levels [e.g., Saw Palmetto and PC-SPES]) other than LHRH agonist/antagonist or a stable dose of corticosteroid from a prior chemotherapy regimen must discontinue the agent for at least 28 days prior to enrollmentXx_NEWLINE_xXPatients who have taken herbal medications and certain fruits within 7 days prior to starting study drug, see section 11.1.2.7.Xx_NEWLINE_xX< 28 days for any antibodies or biological therapiesXx_NEWLINE_xXThe subject has received systemic antineoplastic therapy within 14 days of study treatment, (however, hydroxyurea or 6-mercaptopurine can be given for the purposes of cytoreduction up to one day prior to enrollment, with the exceptions noted above in the inclusion criteria)Xx_NEWLINE_xXThe subject has concurrent uncompensated hypothyroidism or thyroid dysfunction within 10 days before the first dose of study treatmentXx_NEWLINE_xXMale and female patients must agree not to donate sperm or eggs, respectively, from the first dose of study drug through 105 days and 45 days after the last dose of study drug, respectively.Xx_NEWLINE_xXUse of antineoplastic therapies within 21 days before day 1.Xx_NEWLINE_xXImmunotherapy =< 28 days prior to pre-registration (e.g. intravesical Bacillus Calmette-Guerin [BCG])Xx_NEWLINE_xXPatient taking enzyme-inducing anti-epileptic drug (EIAED) < 7 days of the first dose of PQR309.Xx_NEWLINE_xXPatient is currently using herbal preparations or medications. Patient should stop using herbal medications 7 days prior to the first dose of the study drug.Xx_NEWLINE_xXAnti-cancer therapy within 28 days prior to the first dose of study-drug treatment in Cycle 1Xx_NEWLINE_xXPatient has fully recovered from the acute effects of all prior therapy and must meet the following criteria\r\n* At least 14 days must have elapsed since the completion of myelosuppressive therapy\r\n* At least 24 hours must have elapsed since the completion of low-dose of low-dose or non-myelosuppressive therapy, such as hydroxyurea or low-dose cytarabine (up to 200 mg/m^2/day)\r\n* At least 30 days must have elapsed since the use of investigational agents\r\n* For patients who have received prior HSCT, there can be no evidence of GVHD and greater than 60 days must have elapsed since the HSCT; patients cannot be receiving therapy, including steroids, for GVHD; all such medications must be discontinued at least 72 hours prior to enrollmentXx_NEWLINE_xXPatients who have received donor lymphocyte infusion (DLI) within 28 days of Viralym-C infusion.Xx_NEWLINE_xXPatients who have received other investigational drugs within 28 days of Viralym-C infusionXx_NEWLINE_xXRadiation for symptomatic lesions within 14 days of study enrollmentXx_NEWLINE_xXReceipt of lapatinib within 7 days of scheduled dosing day 1.Xx_NEWLINE_xXConcurrent or prior use of immunosuppressive medication within 14 daysXx_NEWLINE_xXSubjects must not have been taking any lithium or lithium containing medications within 90 days prior to study enrollmentXx_NEWLINE_xXSubjects who have received any other investigational agents within 30 days of first lithium doseXx_NEWLINE_xXAnti-tumor therapy within 14 days of study day 1Xx_NEWLINE_xXAt least 7 days must have passed after the last treatment with a biologic agent; for agents that have known adverse events occurring beyond 7 days from administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chairXx_NEWLINE_xXPatients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the prior 7 daysXx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must meet all of the following major inclusion criteria to be eligible for the\n        study:\n\n          1. 18 years of age or older\n\n          2. Histologically or cytologically documented stage IV ductal adenocarcinoma of the\n             pancreas.\n\n          3. Performance Status (ECOG) 0 or 1\n\n          4. FFPE tumor tissue from metastatic site(s\n\n          5. Adequate organ function\n\n          6. Written consent on an IRB/IEC-approved Informed Consent Form prior to any\n             study-specific evaluation.\n\n          7. For women of child-bearing potential, negative serum pregnancy test at screening and\n             use of physician-approved method of birth control from 30 days prior to the first\n             study drug administration to 30 days following the last study drug administration.\n\n          8. Male subjects must be surgically sterile or must agree to use physician-approved\n             contraception from 30 days prior to the first study drug administration to 30 days\n             following the last study drug administration.\n\n        Exclusion Criteria:\n\n        Subjects who meet any of the following major exclusion criteria will not be eligible for\n        participation in the study:\n\n          1. Neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas.\n\n          2. Known brain metastases.\n\n          3. Prior therapy, including systemic therapy, surgical resection or radiation for newly\n             diagnosed stage IV pancreatic cancer.\n\n          4. Presence of any serious or unstable concomitant systemic disorder incompatible with\n             the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including\n             active infection, arterial thrombosis, symptomatic pulmonary embolism).\n\n          5. Any disorder that would significantly compromise protocol compliance.\n\n          6. Prior non-pancreatic malignancy treated with chemotherapy. Prior malignancies treated\n             with surgery and/or radiotherapy alone must be in remission ?3 years. The following\n             prior malignancies are allowable irrespective of when they occurred: in situ carcinoma\n             of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and\n             nonmelanotic skin cancer.\n\n          7. Known human immunodeficiency virus (HIV) infection.\n\n          8. Females who are pregnant or breastfeeding.Xx_NEWLINE_xXAn interval shorter than 21 days from the last dose of chemotherapy or HER2-directed\n             therapy until the time of randomizationXx_NEWLINE_xXmitomycin-C or nitrosoureas within 42 daysXx_NEWLINE_xXinvestigational drug within the 28 days prior to planned first dose of study drug, orXx_NEWLINE_xXmitomycin-C or nitrosoureas within 42 days prior to planned first dose of study drug. Note: Patients receiving LHRH agonists or antagonists or antiestrogens or aromatase inhibitors started and at a stable dose for at least 90 days prior to planned first dose of study drug are eligible. Patients are permitted one 28 day cycle of concurrent treatment with hydroxyurea during the study.Xx_NEWLINE_xXUse of any other experimental drug or therapy within 14 days of baselineXx_NEWLINE_xXAdministration of any investigational drug within 28 days prior to receipt of enzalutamide, abiraterone, prednisone or denosumabXx_NEWLINE_xXPatients can be on steroids as long as the dose has been stable for >= 7 daysXx_NEWLINE_xXPrior hormone therapy is allowed, but last dose must be at least 14 days prior to first dose of MEDI4276.Xx_NEWLINE_xXThe two measurements are spaced at least 14 days apart;Xx_NEWLINE_xXFemale subject must not be breastfeeding at screening or during the study period, and for 60 days after the final study drug administration.Xx_NEWLINE_xXFemale subject must not donate ova starting at screening and throughout the study period and for 60 days after final study drug administration.Xx_NEWLINE_xXMale subject must not donate sperm starting at screening and throughout the study period and for 120 days after final study drug administration.Xx_NEWLINE_xXSubject has had any of the following within 14 days prior to the first dose of study drug:Xx_NEWLINE_xXUse of other investigational drugs within 28 days preceding the first dose of vemurafenib on this study.Xx_NEWLINE_xXCytomegalovirus (CMV): Ongoing infection, treatment, or prophylaxis within the past 28 daysXx_NEWLINE_xXagree not to try to become pregnant during the study and for 90 days after the final study drug administration;Xx_NEWLINE_xXAdequate liver and renal functions as assessed by the following laboratory requirements to be conducted within 14 days before the first dose of study drug:Xx_NEWLINE_xXTreatment with any investigational product within 28 days prior to signing the ICF.Xx_NEWLINE_xXHave received treatment with any drug that has not received regulatory approval for that indication within the 30 days prior to study entryXx_NEWLINE_xXKey inclusion criteria:\n\n          -  Histologically confirmed aggressive diffuse large B-cell lymphoma (DLBCL), including\n             follicular lymphoma (FL) transforming to DLBCL, transformed indolent lymphoma, mantle\n             cell lymphoma (MCL), or Grade 3B FL for dose-escalation cohorts. Only participants\n             with DLBCL will be enrolled in the dose-expansion cohort.\n\n          -  Willing to provide a fresh tumor sample\n\n          -  Evaluable/measurable disease with measurable disease defined as greater than or equal\n             to (>= 1) lesion less than or equal to (<=) 20 mm in one dimension or ? 15 mm in 2\n             dimensions as measured by conventional or high-resolution (spiral) computed tomography\n             (CT). Disease evaluable by the International Working Group criteria (Cheson et al,\n             2007). (NOTE: Irradiated lesions will not be evaluable.)\n\n          -  Baseline fludeoxyglucose positron emission tomography (FDG-PET) or FDG-PET/CT scans\n             must show positive lesions compatible with CT-defined anatomical tumor sites.\n\n          -  Relapsed from or refractory to >= 2 prior chemotherapy regimens with >= 1 regimen\n             containing rituximab or failed 1 prior rituximab-containing regimen and unable to\n             tolerate additional multiagent chemotherapy. NOTE: Subjects enrolled in the\n             dose-escalation portion of the study must have exhausted all available standard\n             therapy.\n\n          -  At least 100 days past autologous stem cell transplant (ASCT).\n\n          -  At least 1 year past allogeneic stem-cell transplant (SCT) and off immunosuppression\n             therapy, with no evidence of graft-versus-host disease.\n\n          -  Eastern Cooperative Oncology Group performance status 0-2.\n\n          -  Adequate hematological function\n\n          -  Adequate organ function\n\n          -  Females of childbearing potential who are sexually active with a nonsterilized male\n             partner must use a highly effective method of contraception for 30 days prior to the\n             first dose of investigational product, and must agree to continue using such\n             precautions for 180 days after the final dose of investigational product.\n\n          -  Nonsterilized males who are sexually active with a female partner of childbearing\n             potential must use a highly effective method of contraception from Day 1through 90\n             days after receipt of the final dose of investigational product.\n\n        Key exclusion criteria:\n\n          -  Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy\n             for treatment of cancer.\n\n          -  Receipt of any experimental therapy, mAb, cancer vaccine, chemotherapy or small\n             molecule within 28 days prior to Cycle 1 Day 1 or 5 half-lives of that therapy,\n             whichever is shorter.\n\n          -  Previous therapy directed against cluster of differentiation 19 (CD19)\n\n          -  Prior exposure to immunotherapy such as but not limited to other anti-cytotoxic\n             T-lymphocyte-associated antigen-4 (CTLA-4), anti-PD 1, or anti-PD-L1 antibodies\n             excluding cancer vaccines.\n\n          -  Vaccination with a live virus within 28 days prior to receiving the first dose of\n             study drug\n\n          -  History of other invasive malignancy within 2 years except for cervical carcinoma in\n             situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast\n             that has been surgically cured.\n\n          -  Evidence of significant active infection requiring antimicrobial, antifungal,\n             antiparasitic, or antiviral therapy or for which other supportive care is given unless\n             the subject is clinically stable.\n\n          -  Human immunodeficiency virus (HIV) positive serology or acquired immunodeficiency\n             syndrome (AIDS).\n\n          -  Active hepatitis B\n\n          -  Ongoing >= Grade 2 toxicities from previous cancer therapies or any unresolved > Grade\n             1 immune-related adverse event (irAE) event unless specifically allowed in the\n             inclusion/exclusion criteria.\n\n          -  No immunosuppressive therapy within 14 days of Cycle 1 Day 1 of MEDI0680 (AMP-514)\n             dosing.\n\n          -  Active or prior documented autoimmune or inflammatory disease except vitiligo.\n\n          -  History of primary immunodeficiency.\n\n          -  Major surgical procedures (as defined by the principal investigator) within 28 days of\n             Cycle 1 Day 1 or still recovering from prior surgery.\n\n          -  History of tuberculosis, including those who may have completed prophylactic isoniazid\n             (INH) therapy.\n\n          -  Documented current central nervous system (CNS) involvement, leptomeningeal disease,\n             or spinal cord compression.\n\n          -  Pregnancy or lactation.\n\n          -  Clinically significant abnormality on electrocardiogram (ECG).\n\n          -  Uncontrolled inter-current illness including, but not limited to, ongoing or active\n             infection, current pneumonitis, symptomatic congestive heart failure, uncontrolled\n             hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease,\n             or psychiatric illness/social situations that would limit compliance with study\n             requirement, substantially increase risk of incurring AEs from MEDI-551 or MEDI0680\n             (AMP-514), or compromise the ability of the subject to give written informed consent.Xx_NEWLINE_xXPatients is off or on a stable dose of immunosuppressive drugs for management or prophylaxis of graft-versus-host disease (GVHD) (defined as no escalation of therapy for GVHD) within 14 days prior to starting crenolanibXx_NEWLINE_xXTreatment within 28 days prior to Dose 1 with:Xx_NEWLINE_xXMitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.Xx_NEWLINE_xXReceived anticoagulation therapy with Coumadin or equivalent vitamin K antagonists within the last 28 daysXx_NEWLINE_xXNo use of PPIs within 5 days before the first dose of alisertib.Xx_NEWLINE_xXExposure to nitrosoureas or mitomycin C within 42 days before the first dose of study drug.Xx_NEWLINE_xXUse of previous EGFR TKIs except afatinib within 3 daysXx_NEWLINE_xXOther baseline laboratory evaluations must be done within 14 days prior to randomization.Xx_NEWLINE_xXTreatments in this category include chemotherapy and targeted therapies not targeting VEGF; 14 days must have elapsed since discontinuation of prior chemotherapeutic treatments for glioma and study treatmentXx_NEWLINE_xXRadiotherapy within 14 days before the first dose of either study drug except localized radiation therapy for lytic bone lesions and plasmacytomasXx_NEWLINE_xXAny of the following clinical laboratory results during screening (i.e., within 28 days before the first dose of either study drug):Xx_NEWLINE_xX14 days must have elapsed since the completion of cytotoxic therapyXx_NEWLINE_xXAt least 60 days from prior total body irradiation (TBI)Xx_NEWLINE_xXPatients must have received crizotinib monotherapy at 250 mg BID on a continuous dosing schedule for at least 90 days; patients must be planning to start treatment at least three days, but no more than 30 days after discontinuing crizotinib monotherapy; patients who were not able to tolerate 250 mg BID of crizotinib are not eligible for this studyXx_NEWLINE_xXMale patients must have free and total testosterone level obtained within 28 days prior to registrationXx_NEWLINE_xXPre-study history and physical must be obtained with 28 days prior to registrationXx_NEWLINE_xXCROSSOVER (STEP 2) REGISTRATION: Patients must be registered to crossover (Step 2) within 30 days of discontinuing treatment on Arm 2 of this studyXx_NEWLINE_xXCROSSOVER (STEP 2) REGISTRATION: Male patients must have free and total testosterone level obtained within 28 days prior to crossover (Step 2) registrationXx_NEWLINE_xXCROSSOVER (STEP 2) REGISTRATION: Patients must have Zubrod performance status 0-2 within 28 days prior to crossover (Step 2) registrationXx_NEWLINE_xXClinical laboratory values as specified below within 3 days before the first dose of study drug:Xx_NEWLINE_xXUse of anti-cancer treatments within 28 daysXx_NEWLINE_xXInclusion Criteria\n\n        Subjects must meet the following criteria to be eligible for study participation:\n\n          1. At least 18 years at the time of signing the informed consent form.\n\n          2. Able to understand and voluntarily sign an informed consent form prior to any\n             study-related assessments/procedures.\n\n          3. Able to adhere to the study visit schedule and other protocol requirements.\n\n          4. Documented diagnosis of multiple myeloma and measurable disease by serum or urine\n             protein electrophoresis (SPEP or UPEP): SPEP ?0.5 g/dL, UPEP ?200 mg/24 hours, or\n             involved serum free light chain (FLC) level ?10 mg/dL provided the serum FLC ratio is\n             abnormal.\n\n          5. Previously received 1 or more lines of anti-myeloma therapy that must have included\n             both lenalidomide and bortezomib (either separately or in combination).\n\n          6. Documented disease progression during or within 60 days after their most recent line\n             of anti myeloma therapy.\n\n          7. Eastern Cooperative Oncology Group (ECOG) performance status score ?2.\n\n          8. All study participants in the USA must be registered into the mandatory POMALYST REMS™\n             (Risk Evaluation & Mitigation Strategy) program, and be willing and able to comply\n             with the requirements of the POMALYST REMS™ program.\n\n          9. All study participants in the USA who are females of child-bearing potential (FCBP)\n             must adhere to the scheduled pregnancy testing as required in the POMALYST REMS™\n             program.\n\n         10. All study participants outside the USA must agree to comply with the POMALYST® PPRMP\n             requirements.\n\n         11. All subjects must be able and agree to take aspirin (81 or 325 mg) daily as\n             prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low\n             molecular weight heparin).\n\n         12. For females of child bearing potential (FCBP): Agree to use 2 reliable forms of\n             contraception simultaneously or practice complete abstinence from heterosexual contact\n             for at least 28 days before starting study treatment, while participating in the study\n             (including dose interruptions), and for at least 28 days after study treatment\n             discontinuation; must follow pregnancy testing requirements as outlined in the\n             POMALYST REMS™ program or the PPRMP.\n\n         13. For all females: Agree to abstain from breastfeeding during study participation and\n             for at least 28 days after study treatment discontinuation.\n\n         14. For all males: Agree to use a latex or synthetic condom during any sexual contact with\n             FCBP while participating in the study and for at least 28 days following\n             discontinuation from study treatment, even if he has undergone a successful vasectomy.\n\n         15. For all males: Agree to refrain from donating semen or sperm while on study and for at\n             least 28 days after discontinuation from study treatment.\n\n         16. Refrain from donating blood while on study treatment and for at least 28 days after\n             discontinuation from study treatment.\n\n         17. Agree not to share medication.\n\n        Exclusion Criteria\n\n        Subjects with any of the following will be excluded from participation in the study:\n\n          1. Peripheral neuropathy Grade ?2.\n\n          2. Non-secretory multiple myeloma.\n\n          3. Any of the following laboratory abnormalities:\n\n               -  ANC <1,000/µL;\n\n               -  Platelet count <50,000/µL for subjects in whom <50% of bone marrow nucleated\n                  cells are plasma cells; or a platelet count <30,000/µL for subjects in whom ?50%\n                  of bone marrow nucleated cells are plasma cells;\n\n               -  Creatinine clearance (CrCL) <45 mL/min as measured directly or as calculated\n                  according to Cockcroft Gault formula;\n\n               -  Corrected serum calcium >13.5 mg/dL (>3.4 mmol/L);\n\n               -  Hemoglobin <8 g/dL (<4.9 mmol/L; prior red blood cell [RBC] transfusion or\n                  recombinant human erythropoietin use is permitted before study entry);\n\n               -  Serum aspartate aminotransferase (AST) >3.0 x upper limit of normal (ULN);\n\n               -  Serum alanine aminotransferase (ALT) >3.0 x ULN;\n\n               -  Serum total bilirubin >1.5 x ULN (>3.0 x ULN for subjects with known Gilbert's\n                  disease).\n\n          4. Prior history of malignancies, other than MM, unless the subject has been free of the\n             disease for ?5 years. Subjects may be entered earlier than 5 years if they have\n             received curative treatment for the following:\n\n               -  Basal cell carcinoma of the skin;\n\n               -  Squamous cell carcinoma of the skin;\n\n               -  Carcinoma in situ of the cervix;\n\n               -  Carcinoma in situ of the breast;\n\n             Or if they have:\n\n             o Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor,\n             nodes, metastasis] clinical staging system) or non metastatic prostate cancer that is\n             in complete remission or does not require treatment.\n\n          5. Previous therapy with POM and/or MRZ.\n\n          6. History of allergic reaction or hypersensitivity to thalidomide, lenalidomide,\n             bortezomib, carfilzomib, boron, mannitol, or DEX.\n\n          7. Grade ?3 rash during prior thalidomide or lenalidomide therapy.\n\n          8. Gastrointestinal disease that may significantly alter the absorption of POM.\n\n          9. History of the following:\n\n               -  Congestive heart failure of Class III or IV of the New York Heart Association\n                  (NYHA) classification;\n\n               -  Myocardial infarction within 12 months prior to starting study treatment;\n\n               -  Unstable or poorly controlled angina pectoris, including Prinzmetal variant\n                  angina pectoris.\n\n         10. Any of the following within 14 days prior to initiation of study treatment:\n\n               -  Plasmapheresis;\n\n               -  Major surgery (kyphoplasty is not considered major surgery);\n\n               -  Radiation therapy;\n\n               -  Anti-myeloma drug therapy.\n\n         11. Received any investigational agents within 28 days or 5 half-lives (whichever is\n             longer) prior to initiation of study treatment.\n\n         12. Conditions requiring chronic steroid or immunosuppressive treatment (eg, rheumatoid\n             arthritis, multiple sclerosis, or lupus), which likely need additional steroid or\n             immunosuppressive treatments in addition to the study treatment.\n\n         13. Subjects may not receive corticosteroids (>10 mg/day of prednisone or equivalent)\n             within 3 weeks prior to enrollment (use of steroidal inhalation aerosol for asthma is\n             permitted).\n\n         14. Unable or unwilling to undergo antithrombotic prophylactic treatment.\n\n         15. Any condition, including the presence of laboratory abnormalities, which places the\n             subject at unacceptable risk if he/she were to participate in the study, as determined\n             by the Investigator.\n\n         16. Pregnant and/or breastfeeding females.\n\n         17. Known seropositive for or active viral infection with human immunodeficiency virus\n             (HIV).\n\n         18. Known seropositive for or active viral infection with hepatitis B virus (HBV), with\n             the following exceptions:\n\n               -  negative are eligible.\n\n               -  Subjects who had hepatitis B but have received an antiviral treatment and show\n                  non-detectable viral DNA for 6 months are eligible.\n\n               -  Subjects who are seropositive because of hepatitis B virus vaccine are eligible.\n\n         19. Known seropositive for or active viral infection with hepatitis C virus (HCV), with\n             the following exception: Subjects who had hepatitis C but have received an antiviral\n             treatment and show no detectable viral ribonucleic acid (RNA) for 6 months are\n             eligible.Xx_NEWLINE_xXDiagnostic examination under anesthesia (EUA) must be performed within 14 days prior to study entryXx_NEWLINE_xXAt least 4 weeks post-craniotomy (7 days for stereotactic biopsy), within 14 days prior to the start of SL-701, and on a corticosteroid dosage that has been stable or decreasing for at least 5 days.Xx_NEWLINE_xXSignificant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days prior to the first dose of study drugXx_NEWLINE_xXPulmonary hemorrhage of Grade ?2 within 28 days prior to first dose of study treatmentXx_NEWLINE_xXAny major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3), or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3).Xx_NEWLINE_xXHave taken any of the following drugs within 7 days prior to Study Day 1:Xx_NEWLINE_xXUse of investigational drug, other than the study medications specified by the protocol, within 30 days of transplantationXx_NEWLINE_xXStable or decreasing dose of corticosteroids for at least 7 days prior to randomization.Xx_NEWLINE_xXPatients must be on a stable dose of specific targeted therapy (erlotinib or crizotinib) for >= 28 days prior to initiation of ipilimumab/nivolumabXx_NEWLINE_xXPatients are excluded for receiving any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks (28 days) prior to or after any dose of ipilimumabXx_NEWLINE_xXRecent infection requiring IV anti-infective treatment that was completed ?14 days before the first dose of study drugXx_NEWLINE_xXNeurological symptoms related to brain metastasis that are not controlled with a stable or decreasing dose of oral steroids for at least 7 days prior to starting GSK2118436Xx_NEWLINE_xXPlanned treatment with NovoTTF therapy alone per Food and Drug Administration (FDA)-approved indication; NovoTTF therapy must start within 14 days of registration, but not less than 7 days or more than 21 days from stereotactic biopsy (if applicable) and not less than 21 days or more than 42 days from open resection (if applicable)Xx_NEWLINE_xXReceived antithymocyte globulin (ATG), or Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollmentXx_NEWLINE_xXPlatelets ? 100 x 109/L (in case of transfusion stable for ?14 days prior to treatment start)Xx_NEWLINE_xXAnti-thymocyte globulin, alemtuzumab, bortezomib, or cyclophosphamide administered within 14 days before or planned to receive with HCT conditioning or as part of GVHD prophylaxis in the 14 days after HCTXx_NEWLINE_xXAntileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)Xx_NEWLINE_xXAt least 14 days must have elapsed for chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity.Xx_NEWLINE_xXImmunotherapy within 21 days prior to randomizationXx_NEWLINE_xXReceipt of an investigational drug within 28 days prior to initiation of study treatmentXx_NEWLINE_xXInclusion Criteria: A subject will be eligible for inclusion in this study only if all of\n        the following criteria are met:\n\n          1. Female subjects, age ? 18 years at the time informed consent is signed\n\n          2. Pathologically confirmed adenocarcinoma of the breast\n\n          3. Pathologically confirmed as triple negative, source documented, defined as both of the\n             following\n\n               1. Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative: < 1% of tumor\n                  cell nuclei are immunoreactive in the presence of evidence that the sample can\n                  express ER or PgR (positive intrinsic controls)\n\n               2. Human Epidermal Growth Factor Receptor 2 (HER2) negative as per American Society\n                  of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines i.\n                  Immunohistochemistry (IHC) 0 or 1 Fluorescence In Situ Hybridization (FISH)\n                  negative (or equivalent negative test). Subjects with IHC 2 must have a negative\n                  by Fluorescence In Situ Hybridization (FISH),, (or equivalent negative test).\n\n          4. Subjects with prior breast cancer history of different phenotypes (ie, ER/PgR/HER2\n             positive) must have pathologic confirmation of triple negative disease in at least one\n             of the current sites of metastasis\n\n          5. Subjects must have received prior adjuvant or neoadjuvant anthracycline therapy;\n             unless (a) anthracycline treatment was not indicated or was not the best treatment\n             option for the subject in the opinion of the treating physician; and (b) anthracycline\n             treatment remains not indicated or, in the opinion of the treating physician, is not\n             the best treatment option for the subject's metastatic disease.\n\n             a. Newly diagnosed subjects presenting with TNMBC are eligible for the study if\n             anthracycline treatment is not indicated or is not the best treatment option for the\n             subject in the opinion of the treating physician.\n\n          6. Subjects with measurable metastatic disease, defined by Response Evaluation Criteria\n             in Solid Tumors 1.1 (RECIST 1.1) guidelines\n\n          7. Life expectancy ? 16 weeks from randomization\n\n          8. No prior cytotoxic chemotherapy for metastatic breast cancer. Prior immunotherapy\n             and/or monoclonal antibody therapy are acceptable. Prior treatments must have been\n             discontinued at least 30 days prior to start of study treatment and all related\n             toxicities must have resolved to Grade 1 or less.\n\n          9. Prior neoadjuvant or adjuvant chemotherapy, if given, must have been completed at\n             least 6 months before randomization with all related toxicities resolved, and\n             documented evidence of disease progression per RECIST 1.1 guidelines is required.\n\n             a. If prior neoadjuvant or adjuvant chemotherapy contained taxane, gemcitabine, or\n             platinum agents, the treatment must have completed at least 12 months before\n             randomization\n\n         10. Prior radiotherapy must have completed before randomization, with full recovery from\n             acute radiation side effects. At least one measurable lesion must be completely\n             outside the radiation portal or there must be unequivocal radiologic or clinical exam\n             proof of progressive disease within the radiation portal, in accordance with RECIST\n             1.1 guidelines\n\n         11. At least 30 days from major surgery before randomization, with full recovery\n\n         12. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n\n         13. Subject has the following blood counts at screening:\n\n               -  Absolute Neutrophil Count (ANC) ? 1500/mm^2 ;\n\n               -  Platelets ? 100,000/mm^2 ;\n\n               -  Hemoglobin (Hgb) ? 9 g/dL\n\n         14. Subject has the following blood chemistry levels at screening:\n\n               -  Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT),\n                  Alanine Aminotransferase (ALT ) Serum Glutamic Pyruvate Transaminase (SGPT) ? 2.5\n                  x upper limit of normal range (ULN); if hepatic metastases present ? 5.0 x ULN\n\n               -  Total serum bilirubin ? ULN; or total bilirubin ? 3.0 × ULN with direct bilirubin\n                  within normal range in subjects with documented Gilbert's Syndrome\n\n               -  Creatinine clearance > 60 mL/min (by Cockcroft-Gault)\n\n         15. Females of child-bearing potential [defined as a sexually mature women who (1) have\n             not undergone hysterectomy (the surgical removal of the uterus) or bilateral\n             oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally\n             postmenopausal for at least 24 consecutive months (i.e., has had menses at any time\n             during the preceding 24 consecutive months)] must:\n\n               -  Demonstrate a negative serum pregnancy test result at screening (performed by\n                  central lab) confirmed by local negative urine pregnancy dipstick within 72 hours\n                  prior to the first dose of IP); pregnancy test with sensitivity of at least 25\n                  mIU/mL; and\n\n               -  Either commit to true abstinence* from heterosexual contact (which must be\n                  reviewed on a monthly basis) or agree to use, and be able to comply with, two\n                  physician approved effective contraception methods (oral, injectable, or\n                  implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier\n                  contraceptive with spermicide; or vasectomized partner) without interruption for\n                  28 days or longer as required by local guidelines, prior to starting study drug,\n                  during the study therapy (including dose interruptions), and for 28 days after\n                  discontinuation of the study or longer as required by local guidelines\n\n         16. Females must abstain from breastfeeding starting at randomization, during study\n             participation and for 28 days or longer as required by local guidelines, after IP\n             discontinuation\n\n         17. Understand and voluntarily sign an informed consent document prior to any study\n             related assessments/procedures are conducted\n\n         18. Able to adhere to the study visit schedule and other protocol requirements\n\n        Exclusion Criteria:\n\n        A subject will not be eligible for inclusion in this study if any of the following criteria\n        apply:\n\n          1. Male subjects\n\n          2. Concurrent chemotherapy or any other anti tumor therapy for breast cancer. Prior\n             immunotherapy & monoclonal antibody therapy are acceptable.\n\n          3. Subjects who received prior cytotoxic chemotherapy after incomplete resection of\n             locoregional recurrent disease\n\n          4. History of, or known current evidence of brain metastasis, including leptomeningeal\n             involvement.\n\n          5. Subjects with bone as the only site of metastatic disease\n\n          6. Subjects with regional lymph node as the only site of metastatic disease\n\n          7. Serious intercurrent medical or psychiatric illness, including serious active\n             infection\n\n          8. History of class II-IV congestive heart failure or myocardial infarction within 6\n             months of randomization\n\n          9. History of other primary malignancy in the last 5 years prior to randomization.\n             Subjects with prior breast cancer history are eligible, however, the most recently\n             obtained biopsy must demonstrate triple negative disease (source documented). Subjects\n             with prior history of in situ cancer or basal or localized squamous cell skin cancer\n             are eligible.\n\n         10. Subjects with a history of interstitial lung disease, history of slowly progressive\n             dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis,\n             pulmonary hypersensitivity pneumonitis or multiple uncontrolled or unstable allergies\n             which, in the opinion of the investigator, may lead to serious complications\n\n         11. Peripheral neuropathy Grade ? 2 by National Cancer Institute Common Terminology\n             Criteria for Adverse Events (NCI CTCAE) v4.0\n\n         12. Subjects who have received an investigational product within the previous 4 weeks\n             prior to randomization\n\n         13. Subject is currently enrolled, or will enroll in a different clinical study in which\n             investigational therapeutic procedures are performed or investigational therapies are\n             administered while participating in this study\n\n         14. Pregnant or nursing women\n\n         15. Subjects with prior hypersensitivity to nab-paclitaxel, gemcitabine, carboplatin or\n             any other platin, or nucleoside analogue agents\n\n         16. Any significant medical condition, laboratory abnormality, or psychiatric illness that\n             would prevent the subject from participating in the study\n\n         17. Any condition including the presence of laboratory abnormalities, which places the\n             subject at unacceptable risk if she were to participate in the study\n\n         18. Any condition that confounds the ability to interpret data from the study\n\n         19. History of seropositive human immunodeficiency virus (HIV)\n\n         20. Subjects who are receiving immunosuppressive or myelosuppressive medications that\n             would, in the opinion of the investigator, increase the risk of serious neutropenic\n             complicationsXx_NEWLINE_xXReceiving antibiotic therapy within 14 days before the first dose of study treatmentXx_NEWLINE_xXSystemic antineoplastic therapy within 21 days before the first dose of study drugXx_NEWLINE_xXTreatment with CYP3A inducers within 14 days before the first dose of MLN4924. Treatment with CYP3A inhibitors within 14 days before the first dose of MLN4924; however, voriconazole and fluconazole need only be stopped for 3 days before MLN4924. Patients must have no history of amiodarone use in the 6 months before the first dose of MLN4924Xx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must meet all of the following criteria to be eligible for the study:\n\n          1. Histologically or cytologically documented extensive stage small cell lung cancer.\n\n          2. Adults of 18 years of age or older.\n\n          3. Performance Status (ECOG) of 0 or 1.\n\n          4. FFPE tumor tissue.\n\n          5. Adequate organ function:\n\n               1. Adequate hematologic function (absolute neutrophil count [ANC] ? 1,500 cells/?L;\n                  hemoglobin ? 9 g/dL, platelets ? 100,000/?L).\n\n               2. Adequate renal function (serum creatinine ? 1.5 mg/dL or calculated creatinine\n                  clearance ? 60 mL/min using Cockcroft-Gault formula).\n\n               3. Adequate hepatic function (alanine aminotransferase [ALT] ? 3 x upper limit of\n                  normal [ULN], ALT may be ? 5 x ULN if due to liver metastases but cannot be\n                  associated with concurrent elevated bilirubin >1.5xULN unless it is approved by\n                  the Sponsor's Medical Monitor).\n\n               4. Prothrombin Time (PT)/International Normalized Ration (INR) ?1.5 × ULN, activated\n                  partial thromboplastin time (aPTT) ?1.5 × ULN.\n\n          6. Written consent on an IRB/IEC-approved Informed Consent Form prior to any\n             study-specific evaluation.\n\n          7. For women of child-bearing potential, negative serum pregnancy test at screening and\n             use of physician-approved method of birth control from 30 days prior to the first\n             study drug administration to 30 days following the last study drug administration or\n             the last EP in the study, whichever is discontinued last.\n\n          8. Male subjects must be surgically sterile or must agree to use physician-approved\n             contraception during the study and for 30 days following the last study drug\n             administration or the last EP in the study, whichever is discontinued last.\n\n        Exclusion Criteria:\n\n        Subjects who meet any of the following criteria will not be eligible for participation in\n        the study:\n\n          1. Limited stage small cell lung cancer appropriate for radical treatment with\n             chemoradiation.\n\n          2. Prior therapy including radiation, chemotherapy or surgery for newly diagnosed\n             extensive stage small cell lung cancer.\n\n          3. Presence of any serious or uncontrolled illness including, but not limited to: ongoing\n             or active infection, symptomatic congestive heart failure unstable angina pectoris,\n             uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis, symptomatic\n             pulmonary embolism, and psychiatric illness that would limit compliance with study\n             requirement.\n\n          4. History of myocardial infarction, acute coronary syndromes (including unstable\n             angina), coronary angioplasty and/or stenting within 6 months prior to the first\n             administration of study drug.\n\n          5. A history of malignancy with the exception of:\n\n               1. Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or\n                  in situ cervical cancer\n\n               2. Adequately treated stage I cancer from which the subject is currently in\n                  remission, or\n\n               3. Any other cancer from which the subject has been disease-free for ? 3 years\n\n          6. Known human immunodeficiency virus (HIV) infection.\n\n          7. Females who are pregnant or breastfeeding.\n\n          8. Concurrent use of therapeutic warfarin (prophylactic low dose of warfarin, i.e., 1 mg\n             daily for port catheter is allowed)Xx_NEWLINE_xXCompletion of last anti-cancer therapy must be at least 28 days prior to study drug administration.Xx_NEWLINE_xXSubject who requires parenteral nutrition, tube feeding or has evidence of partial bowel obstruction or perforation within 28 days prior to study drug administration.Xx_NEWLINE_xXPeripheral blood blast ? 5% Be able to start study therapy between 42 to 84 days following allogeneic HSCT Post transplant bone marrow blast count ? 5% confirmed within 21 days prior to starting study therapy Adequate engraftment within 14 days prior to starting study therapy:Xx_NEWLINE_xXDexamethasone (or equivalent systemic steroid) higher than the physiologic dosing with 7 days before study drug administrationXx_NEWLINE_xXSubject has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drugXx_NEWLINE_xXSubject has received aspirin or warfarin within 7 days prior to the first dose of study drugXx_NEWLINE_xXSubject has received rifampin within 4 days prior to first dose of ABT-263Xx_NEWLINE_xXGlucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasoneXx_NEWLINE_xXTrastuzumab =< 21 days before first study treatmentXx_NEWLINE_xXLapatinib =< 14 days before first study treatmentXx_NEWLINE_xXCurrent use of any platelet functioning inhibitors (including aspirin) within 14 days of first on-study thrombokinetic studyXx_NEWLINE_xXRecent (i.e., within the past 28 days prior to randomization) or current participation in another experimental drug studyXx_NEWLINE_xXTreatment with CYP3A inducers within 14 days before the first dose of MLN4924Xx_NEWLINE_xXSystemic antineoplastic therapy or radiotherapy within 14 days before the first dose of study drug, except for hydroxyureaXx_NEWLINE_xXPatient has received other investigational drugs with 14 days before enrollmentXx_NEWLINE_xXPatients who have not discontinued all prior medical therapy for breast cancer (with the exception of bisphosphonates or denosumab) at least 21 days prior to first dose of orteronel; this includes patients who have received other investigational agents within 21 days prior to the first dose of orteronelXx_NEWLINE_xXContinuous corticosteroid therapy within 21 days prior to first dose of orteronelXx_NEWLINE_xXPatients must have a history and physical examination obtained within 28 days prior to registrationXx_NEWLINE_xXAnti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowedXx_NEWLINE_xXHas been on mechanical ventilation for > 28 daysXx_NEWLINE_xXPatient has received other investigational drugs with 14 days before enrollmentXx_NEWLINE_xXTreatment with the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of MLN8237 and during the studyXx_NEWLINE_xXReceived one prior cycle of fulvestrant within 28 days of randomization are eligible.Xx_NEWLINE_xXClinical laboratory values as specified within 14 days of treatment:Xx_NEWLINE_xXTreatment with an experimental drug within 28 days of first doseXx_NEWLINE_xXAngina pectoris ? 3 months prior to starting study drugXx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must meet all of the following criteria to be eligible for the study:\n\n          1. Age >18 years\n\n          2. ECOG performance status <2 (see Appendix B)\n\n          3. Solid tumor malignancy for which there is no remaining standard therapy or either\n             refuse or are not considered to be candidates for any remaining standard therapy.\n\n          4. Must have a tumor that is measurable or evaluable per RECIST v1.1 in the dose\n             escalation phase. In the expansion cohort(s), subjects must have measurable disease.\n\n          5. Subjects must have Formalin-Fixed, Paraffin-Embedded (FFPE) tissue available either\n             archived or fresh core or punch needle biopsied at study entry (two fresh\n             cores/punches preferred whenever possible) for determination of Notch1 pathway\n             activation status.\n\n          6. Must have received their last chemotherapy, biologic, radiotherapy, or investigational\n             therapy at least 4 weeks prior to enrollment; 6 weeks if the last regimen included\n             BCNU or mitomycin C.\n\n          7. Subjects must have normal organ and marrow function as defined below:\n\n               -  Absolute neutrophil count >1500/mL without growth factor support in the past 7\n                  days\n\n               -  Platelets >100,000/mL without transfusions in the past 7 days\n\n               -  Total bilirubin <1.5 X institutional upper limit of normal (ULN) (<2X ULN for\n                  subjects with Gilbert's syndrome)\n\n               -  AST (SGOT) and ALT (SGPT) <3 X institutional ULN (for subjects with hepatic\n                  involvement <5 X institutional ULN but cannot be associated with elevated\n                  bilirubin)\n\n               -  PT/INR and aPTT within 1.5 X institutional ULN\n\n               -  Creatinine <1.5 X institutional ULN OR\n\n               -  Creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels above\n                  institutional normal\n\n               -  Normal Ejection Fraction (>50%) on ECHO scan or MUGA\n\n          8. Women of childbearing potential must have had a prior hysterectomy or have a negative\n             serum pregnancy test and be using adequate contraception prior to study entry and must\n             agree to use adequate contraception from study entry through at least 6 months after\n             discontinuation of study drug. Men must also agree to use adequate contraception\n             (hormonal or barrier method of birth control; abstinence) prior to study entry and\n             from study entry through at least 6 months after discontinuation of study drug. Should\n             a woman enrolled in the study or a female partner of a man enrolled in the study\n             become pregnant or suspect she is pregnant while participating in this study or within\n             6 months after discontinuation of study, she should inform the Investigator\n             immediately.\n\n          9. Ability to understand and the willingness to sign a written informed consent document\n\n        Exclusion Criteria:\n\n        Subjects who meet any of the following criteria will not be eligible for participation in\n        the study:\n\n          1. Currently receiving any therapeutic treatment for their malignancy including other\n             investigational agents\n\n          2. Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors\n\n          3. Uncontrolled seizure disorder, active neurologic disease, or active CNS involvement\n             except for individuals who have previously-treated CNS metastases, are asymptomatic,\n             and have no requirement for higher doses of corticosteroids (> prednisone 10mg orally\n             per day) or anti-seizure medication for at least 4 weeks prior to first dose of study\n             drug.\n\n          4. History of a Grade 4 allergic reaction attributed to humanized or human monoclonal\n             antibody therapy\n\n          5. Significant intercurrent illness including, but not limited to, ongoing or active\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\n             study requirements\n\n          6. Pregnant women or nursing women\n\n          7. Ongoing malignancies or malignancies in remission <3 years other than the malignancies\n             included in this trial. Patients with history of known squamous cell skin cancers\n             within the past 3 years will not be included in this trial. The following prior\n             malignancies are allowable irrespective of when they occurred: in situ carcinoma of\n             the cervix, in situ ductal breast cancer, and low-grade local bladder cancer.\n\n          8. Subjects with known HIV infection\n\n          9. Known bleeding disorder or coagulopathy\n\n         10. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.\n\n         11. Hemoptysis in excess of 2.5 mL(or one-half teaspoon) within 8 weeks of first dose of\n             study drug.\n\n         12. Subjects receiving heparin, warfarin, or other similar anticoagulants, except for\n             subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be\n             receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.\n\n         13. New York Heart Association Classification II, III, or IV (see Appendix D)\n\n         14. Subjects with poorly controlled blood pressure (defined as systolic blood pressure\n             ?140 mmHg or diastolic blood pressure ?90 mmHg) that is not responsive to medical\n             therapy. Subjects taking antihypertensive medications must be taking ?2 medications to\n             obtain this level of blood pressure control.\n\n             NOTE: Initiation or adjustment of antihypertensive medication(s) is permitted prior to\n             study entry.\n\n         15. Subjects with ECG evidence of ischemia or ?Grade 2 ventricular arrhythmia, subjects\n             who have a history of acute myocardial infarction within 6 months, or subjects with\n             unstable angina.\n\n         16. Subjects with known clinically significant gastrointestinal disease including, but not\n             limited to:\n\n               -  inflammatory bowel disease\n\n               -  active peptic ulcer disease\n\n               -  known intraluminal metastatic lesion(s) with risk of bleeding\n\n               -  history of abdominal fistula, GI perforation, or intra-abdominal abscess within\n                  28 days prior to beginning study treatment\n\n         17. Subjects with diarrhea at time of enrollment or have an ongoing requirement for anti\n             diarrheal therapyXx_NEWLINE_xXSerum direct bilirubin =< 2 mg/dL (34 umol/L) within 14 days prior to randomizationXx_NEWLINE_xXUse of any other experimental drug or therapy within 21 days of baselineXx_NEWLINE_xXBlood or albumin transfusion within 5 days prior to the blood draw being used to confirm eligibilityXx_NEWLINE_xXSubject had a painful crisis requiring hospitalization within the preceding 14 days or has experienced > 5 hospitalizations for VOC in the prior 6 monthsXx_NEWLINE_xXSubject has been transfused within the past 14 daysXx_NEWLINE_xXChemotherapy or any other investigational agents within 14 days of first receipt of study treatment, or major surgery within 28 days of first receipt of study treatment, or palliative radiation within 7 days of first receipt of study treatmentXx_NEWLINE_xXShould be off any active therapy for AML with the exception of hydroxyurea for at least 14 days prior to study registration unless patient has rapidly progressive disease, and all grade 2-4 non-hematologic toxicities should have resolvedXx_NEWLINE_xXSerum creatinine =< 1.5 x IULN (assessed within 7 days prior to study day 1)Xx_NEWLINE_xXWCBP must agree to have pregnancy tests monthly (every 14 days for women with irregular cycles) while on study drug and 4 weeks after the last dose of study drugXx_NEWLINE_xXAny of the following recent therapies:\r\n* Alkylators (e.g. melphalan, cyclophosphamide) =< 14 days prior to registration\r\n* Anthracyclines =< 14 days prior to registration\r\n* High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (bortezomib) =< 7 days prior to registrationXx_NEWLINE_xXFor purposes of determining prior drug regimens the following should be used as a standard; radiation therapy counts as 1 treatment, BMT including induction counts as one treatment, radioimmunotherapy is not considered a chemotherapy regimen, and rituximab alone is not considered a treatment; all prior therapy must have been completed at least 30 days prior to registration; patients should not have taken valproic acid, or any other histone deacetylase inhibitor (e.g., vorinostat, romidepsin), for at least 30 days prior to registration; patients must have recovered from any toxicities related to therapies prior to registrationXx_NEWLINE_xXPatients must have an electrocardiogram (EKG) with no significant abnormalities within 28 days prior to registrationXx_NEWLINE_xXThe last dose administered of bevacizumab must be at least 21-days but not more than 56-days from enrollmentXx_NEWLINE_xXOff study use of ketorolac or other NSAIDs prior to study administrationXx_NEWLINE_xXReceipt of an investigational drug within 28 days prior to study startXx_NEWLINE_xXPrior chemotherapy or surgery must have been completed at least 28 days prior to registration, and all toxicities must have resolvedXx_NEWLINE_xXWilling to discontinue use of medications that inhibit platelet function >= 10 days prior to registration; aspirin at doses greater than 325 mg/day must be discontinued >= 10 days prior to registration and avoided through the study; note: nonsteroidal anti-inflammatory drug (NSAID) medications are recommended in place of aspirin; if NSAIDs or aspirin are used, histamine (H)-2 blockers and proton pump inhibitor (PPI) medications are recommendedXx_NEWLINE_xXMyelosuppressive therapy for myeloma =< 14 days prior to registration or those who have not recovered from acute reversible adverse events due to agents administered > 21 days earlierXx_NEWLINE_xXMyelosuppressive chemotherapy: Last dose was given at least 14 days before the start date for protocol therapy.Xx_NEWLINE_xXBiologic (anti-neoplastic agent including retinoids): Last dose given at least 7 days prior to the start date for protocol therapy.Xx_NEWLINE_xXPrior treatment with: anti-cancer therapy (e.g., chemotherapy with delayed toxicity, immunotherapy, biologic therapy or chemoradiation) within 21 days (or within 42 days if prior nitrosourea or mitomycin C containing therapy) prior to enrollment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to enrolment. Subjects may remain on luteinizing hormone releasing hormone (LHRH) agonists (i.e., leuprolide, goserelin, triptorelin or histrelin). Subjects must have prior enzalutamide treatment; Any PI3K, AKT or mammalian target of rapamycin (mTOR) inhibitors; Investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to enrollmentXx_NEWLINE_xXRadiation directed at target lesion within 28 days of registrationXx_NEWLINE_xXBilirubin =< 1.5 x ULN, within 14 days prior to initiation of study drugXx_NEWLINE_xXHematologic parameters must be assessed at least 14 days after a prior transfusion, if anyXx_NEWLINE_xXPatients must have recovered from the toxic effects of prior therapy, and there must be a minimum time of: \r\n* 28 days from the administration of any investigational agent\r\n* 28 days from administration of prior cytotoxic therapy with the following exceptions: \r\n** 14 days from administration of vincristine\r\n** 42 days from administration of nitrosoureas\r\n** 21 days from administration of procarbazine\r\n* 7 days from administration of non-cytotoxic agents (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. [radiosensitizer does not count])\r\n* 28 days from prior radiation therapyXx_NEWLINE_xXResidual disease following resection of recurrent tumor is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, an MRI should be done no later than 96 hours in the immediate postoperative period or at least 4 weeks postoperatively, within 14 days prior to registration; if the \within 96-hour of surgery\ scan is more than 14 days before registration, the scan needs to be repeatedXx_NEWLINE_xXEvidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 14 days prior to registrationXx_NEWLINE_xXPatients cannot be receiving CYP3A4 inhibitors beginning at least 7 days prior to registration step 2Xx_NEWLINE_xXHave received prior systemic anti-cancer therapy within 1 month of the first dose of AG-120 or AG-881 or have received an investigational agent <14 days prior to their first dose of AG-120 or AG-881. In addition, the first dose of AG-120 or AG-881 should not occur before a period of ?5 half-lives of the investigational agent has elapsed.Xx_NEWLINE_xXBiologic agent (i.e., antibodies) for anti-neoplastic intent within 30 daysXx_NEWLINE_xXCAR-T infusion or other cellular therapy within 30 daysXx_NEWLINE_xXParticipants who are less than 100 days post-transplant, or greater than or equal to 100 days post-transplant with active graft versus host disease (GVHD), or are receiving immunosuppressant therapy within 7 days prior to first dose of study drug.Xx_NEWLINE_xXImmunotherapy within 21 days prior to randomization.Xx_NEWLINE_xXTreatment with valproic acid within 14 days prior to initiation of study and during the studyXx_NEWLINE_xXPatients who have not yet completed at least 28 days (30 days for prior monoclonal antibody therapy) since receiving other investigational drugsXx_NEWLINE_xXAt least 30 days must have elapsed since any prior experimental therapyXx_NEWLINE_xXAge 14-21Xx_NEWLINE_xXAdministration of an investigational therapeutic within 30 days of screeningXx_NEWLINE_xXSystemic corticosteroid therapy <7 days prior to first dose of the study medicationXx_NEWLINE_xXBlood transfusion within 5 days prior to blood draw being used to confirm eligibilityXx_NEWLINE_xXThe systemic use of the following therapies are prohibited within 28 days of first dose of study medication, or longer where indicated:Xx_NEWLINE_xXUse of anti-cancer treatment (including investigational drugs) within 28 daysXx_NEWLINE_xXUse of valproic acid for any medical condition while receiving protocol treatment or within 5 days prior to first panobinostat doseXx_NEWLINE_xXFor women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administrationXx_NEWLINE_xXHave received a systemic corticosteroid within one week prior to the first administration of study drug;Xx_NEWLINE_xXHematocrit > 29% within 14 days prior to treatment initiationXx_NEWLINE_xXPatient has received other investigational drugs within 14 days of treatment initiationXx_NEWLINE_xXReceived an investigational product within 28 days of study treatment or planned to receive within 28 days after vaccine administrationXx_NEWLINE_xXUsed any systemic steroids within 28 days of study treatmentXx_NEWLINE_xXSubjects may be on a biphosphonate provided it had not been initiated within 14 days prior to receiving the first injection of DPX-SurvivacXx_NEWLINE_xXInvestigative drugs within 21 daysXx_NEWLINE_xXTherapy with anticoagulant or antithrombotic agents (including aspirin) within 7 days prior to study drug administrationXx_NEWLINE_xXInvestigational drug use within 28 days of the first dose of PLX3397Xx_NEWLINE_xXFemales of childbearing potential (FCBP) must not become pregnant for 28 days prior to initiation of study drug, during the study, and for 28 days after discontinuationXx_NEWLINE_xXFemales must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuationXx_NEWLINE_xXMales must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this studyXx_NEWLINE_xXPatients with unhealed wounds for more than 30 daysXx_NEWLINE_xXTreatment with any anti-cancer agents within 28 days of study entryXx_NEWLINE_xXTreatment with any anti-cancer agents within 28 days of study entryXx_NEWLINE_xXIncreasing use of daily doses of opioid analgesics within 28 days prior to enrollment in the study.Xx_NEWLINE_xXSubjects must receive 1st dose of sorafenib 5-7 days prior to administration of SRSXx_NEWLINE_xXKey Inclusion Criteria (Part 1 and Part 2):\n\n          -  Confirmed relapsed or refractory MM (measurable disease) or PCL.\n\n          -  Prior treatment regimens for Part 1: Patients should have received at least 2 prior\n             treatment regimens. Prior treatment must have included at least one full cycle of a\n             proteasome inhibitor (e.g., bortezomib or carfilzomib) and at least one full cycle of\n             an IMiD (e.g., thalidomide, lenalidomide or pomalidomide).\n\n          -  Prior treatment regimens for Part 2: Patients should have received 1 to 3 prior\n             treatment regimens. Prior treatment could have included bortezomib only if the disease\n             was not refractory to treatment with bortezomib (refractory defined as documented\n             progression on therapy or within 60 days of completing treatment with bortezomib).\n\n          -  The disease should have progressed per IMWG criteria during or after the last prior\n             treatment regimen.\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n\n          -  Adequate hematology laboratory values without transfusion support and without\n             hematological growth factor support within 2 weeks of screening.\n\n          -  Adequate liver and renal function.\n\n          -  Additional criteria exist.\n\n        Key Exclusion Criteria (Part 1 and Part 2):\n\n          -  Primary amyloidosis.\n\n          -  Peripheral neuropathy ? Grade 2 or neuropathy with pain, regardless of grade.\n\n          -  Concomitant malignancies or previous malignancies with less than a 3-year disease free\n             interval at the time of enrollment (patients with adequately resected basal or\n             squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low\n             grade prostate cancer may enroll irrespective of the time of diagnosis).\n\n          -  Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to\n             first dose of study drug.\n\n          -  Treatment with an investigational medicinal product or device within 28 days prior to\n             first dose of study drug.\n\n          -  Cytotoxic therapy or monoclonal antibodies within 21 days prior to first dose of study\n             drug.\n\n          -  Radiotherapy within 21 days prior to first dose of study drug (if the radiation portal\n             covered ? 5% of the bone marrow reserve, the patient may be enrolled irrespective of\n             the end date of radiotherapy).\n\n          -  Major surgery within 14 days and minor surgery within 7 days prior to first dose of\n             study drug.\n\n          -  Corticosteroid doses > 10 mg/day of prednisone or equivalent within 14 days prior to\n             first dose of study drug.\n\n          -  Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or\n             active hepatitis C.\n\n          -  Additional criteria exist.Xx_NEWLINE_xXAngina pectoris ? 3 months prior to dosing with study drugXx_NEWLINE_xXThe participant has received a recent (within 30 days of enrollment) or is receiving concurrent yellow fever vaccination.Xx_NEWLINE_xXHave received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.Xx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of baselineXx_NEWLINE_xXDonation of blood within the preceding 60 days prior to study registration.Xx_NEWLINE_xXFemale subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drugXx_NEWLINE_xXPrior treatment with cytotoxic anti-cancer therapy (previous cytokine or investigational immunotherapy are permitted, but must be completed 28 days prior to first dose of study medication)Xx_NEWLINE_xXUse of any prohibited medications within 14 days of the first dose of study medicationXx_NEWLINE_xXpatients who received dasatinib within 3 days of starting study drugXx_NEWLINE_xXpatients who received imatinib within 5 days of starting study drugXx_NEWLINE_xXpatients who received hematopoietic growth factors within 7 days of starting study drug or Pegfilgrastim (Neulasta®) within 14 days of starting study drugXx_NEWLINE_xXSubjects with brain metastases are excluded, unless a. All known lesions must be previously treated with surgery or stereotactic radiosurgery, and- b. Brain lesion(s), if still present, must be confirmed stable (i.e. no increase in lesion size) for ?90 days prior to first dose on study (must be documented with two consecutive MRI or CT scans using contrast), and c. Asymptomatic with no corticosteroids requirement for ? 30 days prior to first dose on study, and d. No enzyme-inducing anticonvulsants for ? 30 days prior to first dose on study.Xx_NEWLINE_xXThe patient has received any investigational or non-registered medicinal product other than the study treat-ment within 30 days preceding the first dose of study treatment or plans to receive such a drug during the study period.Xx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days prior to randomizationXx_NEWLINE_xXPrior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomizationXx_NEWLINE_xXThe subject has active infection or fever > 38.5 degrees Celsius (C) within 3 days prior to first dose of study drugXx_NEWLINE_xXOne or more radiation treatment(s) to the chest wall or breast up to a maximum prior dose of 12,000 cGy in the hyperthermia field (not administered less than 28 days prior to enrollment).Xx_NEWLINE_xXTheir neurological function is stable for at least 30 days and either off steroid therapy or on a stable steroid regimen.Xx_NEWLINE_xXPatient must begin therapy within 7 calendar days of registrationXx_NEWLINE_xXThe patient has received any investigational or non-registered medicinal product other than the study medi-cation within 30 days preceding the first dose of study medication or plans to receive such a drug during the study period.Xx_NEWLINE_xXMust commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.Xx_NEWLINE_xXPrevious treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).Xx_NEWLINE_xXNo more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.Xx_NEWLINE_xXReceived investigational therapy or procedure ? 30 days prior to enrollment.Xx_NEWLINE_xXPatients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days and bevacizumab within 28 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatmentXx_NEWLINE_xXSurgery or invasive procedure requiring sutures or staples for closure =< 7 days prior to registrationXx_NEWLINE_xXMinor procedures (such as a central line placement, needle biopsy, thoracentesis, or paracentesis) =< 3 days prior to registrationXx_NEWLINE_xXSubject must be receiving a stable dose of ASP8273 for 14 days minimum and is able to enroll into this rollover study without treatment interruption of study drug, or with no more than 21 consecutive days of treatment interruption in study drug within the parent study.Xx_NEWLINE_xXBleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants, such as warfarin; occasional use of nonsteroidal antiinflammatory drug (NSAID)s and antiplatelet agents such as aspirin, clopidogrel, aggrenox and dipyridamole are not considered exclusionary if taken < 7 days per 28 days; however, if the patient requires chronic use (>= 7 days out of 28 days) of full doses of aspirin or NSAIDs then the patient is excludedXx_NEWLINE_xXPatients must have clinical laboratory values meeting the following criteria within 28 days prior to registration:Xx_NEWLINE_xXPatients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, stem cell transplant or radiotherapy prior to entering this study; all prior treatment-related toxicities must have resolved to =< grade 2 or meet the inclusion/exclusion criteria prior to enrollment\r\n* Myelosuppressive chemotherapy: \r\n** Must be 14 days after the last dose of myelosuppressive chemotherapy (excluding hydroxyurea)\r\n** Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of therapy\r\n* Intrathecal cytotoxic therapy:\r\n** No waiting period is required for patients having received intrathecal cytarabine, methotrexate, and/or hydrocortisone\r\n** At least 14 days must have elapsed since receiving liposomal cytarabine (DepoCyte) by intrathecal injection\r\n** Intrathecal cytarabine given at the time of diagnostic lumbar puncture (LP) to evaluate for relapse prior to study enrollment is allowed\r\n* Biologic (anti-neoplastic agent): \r\n** At least 7 days since the completion of therapy with a biologic agent such retinoids, or DLI (donor lymphocyte infusion without conditioning)\r\n** Note: for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which acute adverse events are known to occur\r\n* Interleukins, Interferons and Cytokines (other than hematopoietic growth factors): \r\n** >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Antibodies: \r\n** >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Radiation therapy (RT):\r\n** At least 14 days after local palliative x-ray telescope (XRT) (small port); at least 84 days must have elapsed if prior traumatic brain injury (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Stem Cell Transplant (SCT) without TBI: \r\n** No evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion\r\n** Patients must be off all systemic immunosuppressive therapy for at least 2 weeks, excluding hydrocortisone for physiologic cortisol replacement\r\n* Growth factors: \r\n** At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Patients must not have received prior exposure to AZD1775Xx_NEWLINE_xXPatients must not have received enzyme inducing anticonvulsants for at least 14 days prior to enrollmentXx_NEWLINE_xXAgree not to try to become pregnant during the study and for 28 days after the final study drug administration,Xx_NEWLINE_xXFemale subject must not be breastfeeding at screening or during the study period, and for 28 days after the final study drug administration.Xx_NEWLINE_xXFemale subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.Xx_NEWLINE_xXSubject has had any of the following within 14 days prior to the first dose of study drug:Xx_NEWLINE_xXAny major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy must not be given within 28 days prior to study enrollment; for daily or weekly chemotherapy without the potential for delayed toxicity, a washout period of 14 days prior to enrollment may be acceptable, and questions related to this can be discussed with study principal investigatorXx_NEWLINE_xXCompletion of last anti-myeloma therapy (if any) must occur at least 14 days before conditioningXx_NEWLINE_xXUnable or unwilling to discontinue use of prohibited medications for at least 28 days prior to the first dose of topotecan/pazopanib and for the duration of the studyXx_NEWLINE_xXAdministration of any non-oncologic investigational drug within 30 days prior to receiving the first dose of topotecan/pazopanibXx_NEWLINE_xXHas the ability to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post procedure,Xx_NEWLINE_xXHistory and physical with neurological examination, steroid documentation, height, and weight within 14 days of registrationXx_NEWLINE_xXPrior anti-cancer therapy within 28 days before the first dose of study drugXx_NEWLINE_xXInitiation of first-line chemotherapy with a platinum-pemetrexed-based regimen within 14 days of registration or planning to initiate within 14 days after registration; no planned initiation of definitive (potentially curative) concurrent chemo-radiationXx_NEWLINE_xXPRIOR TO STEP 1 REGISTRATIONXx_NEWLINE_xXHistory, physical and performance status of 2 or less within 180 days prior to registrationXx_NEWLINE_xXVaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (< 7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the studyXx_NEWLINE_xXPatients who discontinue monoamine oxidase (MAO)-inhibitor (I)’s within 14 days prior to starting the investigational drugXx_NEWLINE_xXHave had treatment with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period; NOTE: participants could have received prochlorperazine and other phenothiazines as antiemetic therapy on a short term basis (i.e., =< 5 days)Xx_NEWLINE_xXStable dose of corticosteroid >= 14 days prior to registrationXx_NEWLINE_xXSelf-reported psychotic symptoms in the last 30 daysXx_NEWLINE_xXAny change in psychotropic medications within the last 30 daysXx_NEWLINE_xXPatients must have a complete physical examination and medical history within 28 days prior to registrationXx_NEWLINE_xXPRIOR TO STEP 2 REGISTRATIONXx_NEWLINE_xXAny change in psychotropic medications in past 30 daysXx_NEWLINE_xXHaving had pain for at least 3 months and at least 15 days with pain in the preceding 30 daysXx_NEWLINE_xXChronic sustained-release opioid use for > 2 weeks duration pre operation (op) (in the 30 days prior to surgery)Xx_NEWLINE_xXChronic systemic corticosteroid use (>14 days) at the time of study enrollment.Xx_NEWLINE_xXLaboratory results within 5 days prior to anticipated initiation of the first post randomization PLT transfusion:Xx_NEWLINE_xXPatient treated with antifibrinolytic agents (including EACA) within 14 days prior to screeningXx_NEWLINE_xX6-MMP:6-TGN ratio >= 40 within 21 days prior to enrollmentXx_NEWLINE_xXReceived cytotoxic chemotherapy within 21 days (or 42 days for nitrosureas or mitomycin C) prior to the first scheduled dose of MEDI7247.Xx_NEWLINE_xXUse of investigational agents, with the exception of gemtuzumab ozogamicin, within 30 daysXx_NEWLINE_xXCurrent or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatmentXx_NEWLINE_xXSerum creatinine < 2.0 x IULN within 28 days prior to registrationXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 2.0 x IULN if not using anticoagulants within 28 days prior to registration; if using anticoagulants, then the value must be within therapeutic range according to the condition for which the patient is being treated within 28 days prior to registrationXx_NEWLINE_xXPatients must have complete physical examination and medical history obtained within 28 days prior to registrationXx_NEWLINE_xXFemale patients may not be breastfeeding at the first dose of talazoparib and must not breastfeed during study participation through 45 days after the last dose of talazoparib.Xx_NEWLINE_xXAre using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuationXx_NEWLINE_xXPatients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy except organ function; patients must meet the following minimum washout periods prior to enrollment:\r\n* At least 14 days after the last dose of myelosuppressive chemotherapy (42 days for nitrosourea or mitomycin C)\r\n* Radiotherapy:\r\n** At least 14 days after local palliative radiation therapy (XRT) (small port);\r\n** At least 90 days must have elapsed after prior total body irradiation (TBI), craniospinal XRT or if > 50% radiation of pelvis;\r\n** At least 42 must have elapsed if other substantial bone marrow (BM) radiation;\r\n** At least 42 days must have passed since last iobenguane (MIBG) or other radionuclide therapy\r\n* At least 7 days following the last dose of a biologic agent; for agents with known adverse events occurring beyond 7 days, this duration must be extended beyond the time in which adverse events are known to occur; if extended duration is required, this should be discussed and approved by the study chair\r\n* Monoclonal antibody: At least 21 days must have elapsed after the last dose of antibody\r\n* At least 14 days following the last dose of long-acting growth factor (e.g. Neulasta) or 7 days following short-acting growth factor\r\n* The patient must have no evidence of graft versus host disease and at least 42 days must have elapsed after transplant, stem cell infusion, or cellular therapy\r\n* At least 3 weeks from prior major surgical procedure; Note: Biopsy and central line placement/removal are not considered major\r\n* The patient must not have received prior CUDC-907 therapy; prior treatment with individual PI3K or HDAC inhibitors is allowed; patients must not have received therapy with the combination of PI3K and HDAC inhibitorsXx_NEWLINE_xXThere must be a minimum of 14 days (i.e., an interval equal to or greater than 14 days) since last treatment with bevacizumab and registrationXx_NEWLINE_xXHistory/physical examination within 14 days prior to registrationXx_NEWLINE_xXWarfarin: In-range INR (usually between 2 and 3) within 14 days prior to registrationXx_NEWLINE_xX28 days from administration of prior cytotoxic therapy with the following exceptions:Xx_NEWLINE_xX14 days from administration of vincristine or irinotecanXx_NEWLINE_xX42 days from administration of nitrosoureasXx_NEWLINE_xX21 days from administration of procarbazineXx_NEWLINE_xXPatient must be maintained on a stable or decreasing dose of corticosteroid for at least 5 days before the baseline scan.Xx_NEWLINE_xXMinimum interval since completion of radiation treatment at the time of registration is 90 days.Xx_NEWLINE_xXLymphocyte count >= 500/uL (obtained within 28 days prior to the first study treatment)Xx_NEWLINE_xXUse of narcotic pain medication, benzodiazepines, or illicit drugs for seven days prior to and during study participationXx_NEWLINE_xXObtained =< 30 days prior to registration: Triglycerides < 500 mg/dLXx_NEWLINE_xXTaking aspirin, nonsteroidal anti-inflammatory agents, or zileuton =< 7 days prior to registration; NOTE: can be waived with permission of study chair (documentation such as an email must be provided)Xx_NEWLINE_xXPatients who have a negative urine pregnancy test prior to enrollment; this should be done as part of pre-admission testing prior to surgery (within 14 days of study enrollment)Xx_NEWLINE_xXSubjects who have taken a neurokinin antagonist within 14 days prior to beginning the BEAM regimenXx_NEWLINE_xXPatient is currently receiving or has received another investigational agent within 30 days or monoamine oxidase inhibitor within 14 days prior to Lazanda administrationXx_NEWLINE_xXAI use > 21 days prior to study enrollmentXx_NEWLINE_xXProtein levels within normal limits (lab results must be within 45 days prior enrollment)Xx_NEWLINE_xXNormal blood counts (lab results must be within 45 days prior enrollment)Xx_NEWLINE_xXNormal chemistries (lab results must be within 45 days prior enrollment)Xx_NEWLINE_xXParticipation in a therapeutic research study within 30 days of baselineXx_NEWLINE_xXRegistration >= 3 days after placement of a new stent or >= 1 days after a stent exchangeXx_NEWLINE_xXReports a fall in the past 30 daysXx_NEWLINE_xXVTE risk score >= 1, using labs drawn within 28 days of consentXx_NEWLINE_xXHepatic dysfunction (elevated transaminases or bilirubin > 3 times normal), drawn within 28 days of consentXx_NEWLINE_xXHas received voriconazole within 5 days prior to starting study therapyXx_NEWLINE_xXReceived one or more of the following drugs within 14 days prior to starting study: rifampin, rifabutin, carbamazepine, phenytoin, nevirapine, long-acting barbituratesXx_NEWLINE_xXPatients must have had a pelvic MRI within 28 days prior to the initiation of treatmentXx_NEWLINE_xXSmoking cessation treatment use in past 30 daysXx_NEWLINE_xXNon-cigarette tobacco use in the past 30 daysXx_NEWLINE_xXPatient should describe fatigue as being present for a minimum of four daysXx_NEWLINE_xXPatients who are local and able to follow-up in the SCC within 30 days if necessaryXx_NEWLINE_xXTreatment has been completed (except hormone therapy) for >= 90 days prior to registrationXx_NEWLINE_xXPresence of CRF >= 30 days prior to registrationXx_NEWLINE_xXCurrently using any other pharmacologic agent to specifically treat fatigue including psychostimulants, antidepressants, etc., although antidepressants used to treat items other than fatigue (such as hot flashes) are allowed if the patient has been on a stable dose for >= 30 days prior to registration and plans to continue for >= 30 days after registration; erythropoietin agents to treat anemia are allowedXx_NEWLINE_xXChronic oral or intravenous systemic steroid use (defined as being used on a regular basis or who have a problem that has required ongoing use of steroids in the last 180 days for greater than 7 days)Xx_NEWLINE_xXNew use of Ambien and/or other benzodiazepines =< 30 days prior to registrationXx_NEWLINE_xXNew use of sleep aids including melatonin =< 30 days prior to registrationXx_NEWLINE_xXSevere co-existing morbidities having a life expectancy of less than 30 daysXx_NEWLINE_xXInitiating or within 30 days of initiating ADTXx_NEWLINE_xXUse of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of randomizationXx_NEWLINE_xXAt least 14 days must have elapsed since the completion of therapy with a monoclonal antibodyXx_NEWLINE_xXPatients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 daysXx_NEWLINE_xXReceiving anastrozole (1 mg) or letrozole (2.5 mg) orally once a day, for >= 21 days prior to registration and plan to continue throughout the duration of studyXx_NEWLINE_xXLaboratory values obtained =< 365* days prior to registration:\r\n* Note: Without medical situations that should change these parameters since they were doneXx_NEWLINE_xXPRIOR TO STEP 1 REGISTRATION:Xx_NEWLINE_xXPRIOR TO STEP 2 REGISTRATION:Xx_NEWLINE_xXHistory and physical examination within 28 days prior to Step 2 registrationXx_NEWLINE_xXPatients must currently be taking one of the following aromatase inhibitor (AI) doses for at least 21 days prior to registration and plans to continue for at least an additional 180 days after registration; patients may have received any number of prior AI therapies, but the first AI therapy must have started no more than 36 months prior to registration:\r\n* Anastrozole (Arimidex) 1 mg daily\r\n* Letrozole (Femara) 2.5 mg daily\r\n* Exemestane (Aromasin) 25 mg dailyXx_NEWLINE_xXPatients who are receiving treatment with narcotics, tramadol, gabapentin, and/or pregabalin must have been taking a stable dose for at least 30 days prior to registrationXx_NEWLINE_xXGrade 3 or 4 diarrhea, rectal bleeding, abdominal cramping, or incontinence of stool =< 7 days prior to registrationXx_NEWLINE_xXPrior use of acupuncture within 3 months prior to the study entryXx_NEWLINE_xXPresence of hot flashes for > 30 days prior to study entryXx_NEWLINE_xXReports a fall in the past 30 daysXx_NEWLINE_xXAt least 28 days since the last chemotherapy or immunotherapy prior to the first dose; at least 14 days since the last radiation prior to the first dose (exception: palliative radiotherapy for pain can be used greater than or equal to (>=) 7 days prior to or after infusion)Xx_NEWLINE_xXConcurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 60 mg/day of prednisone) within 28 days of the first dose of study drugXx_NEWLINE_xXNeutrophils >= 1000/uL, obtained within 14 days of the first dose of study drugXx_NEWLINE_xXHave received other investigational drugs within 28 days prior to enrollmentXx_NEWLINE_xXInclusion Criteria:\n\n        Inclusion Criteria for Enrollment Phase\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\n          -  Histological or cytological diagnosis of Stage IB (tumors greater than or equal to\n             [>/=] 4 centimeters [cm])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the\n             Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee\n             on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009)\n\n          -  Participants must have had complete resection of NSCLC 4-12 weeks (>/=28 days and less\n             than or equal to [</=] 84 days) prior to enrollment and must be adequately recovered\n             from surgery\n\n          -  If mediastinoscopy was not performed preoperatively, it is required that, at a\n             minimum, mediastinal lymph node systematic sampling will have occurred. Systematic\n             sampling is defined as removal of at least one representative lymph node at specified\n             levels. MLND entails resection of all lymph nodes at those same levels. For a right\n             thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left\n             thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear\n             documentation in the operative report or in a separately submitted addendum by the\n             surgeon of exploration of the required lymph node areas, the participant will be\n             considered eligible if no lymph nodes are found in those areas; if participants have\n             documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition;\n             Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative\n             staging imaging results (contrast computed tomography [CT] and positron emission\n             tomography [PET] scans) do not suggest evidence of disease in the mediastinum, the\n             participant will be considered eligible if N2 nodal sampling is not performed per\n             surgeon's decision\n\n          -  Eligible to receive a cisplatin-based chemotherapy regimen\n\n          -  Adequate hematologic and end-organ function\n\n          -  Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or\n             surgically sterile must have a negative serum pregnancy test result within 14 days\n             prior to initiation of cisplatin-based chemotherapy\n\n        Inclusion Criteria for Randomized Phase - Women who are not postmenopausal (>/=12 months of\n        non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy\n        test result within 14 days prior to initiation of atezolizumab or BSC\n\n        Exclusion Criteria:\n\n        Exclusion Criteria for Enrollment Phase\n\n          -  Illness or condition that may interfere with a participant's capacity to understand,\n             follow, and/or comply with study procedures\n\n          -  Pregnant and lactating women\n\n          -  Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy\n             with curative intent, provided that the last dose received was more than 5 years prior\n             to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed\n             upon approval by the Medical Monitor\n\n          -  Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years\n             before enrollment\n\n          -  Treatment with any other investigational agent with therapeutic intent within 28 days\n             prior to enrollment\n\n          -  Participants with hearing impairment\n\n          -  Known sensitivity to any component of the chemotherapy regimen the participant will be\n             assigned to, or to mannitol\n\n          -  Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune\n             checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed\n             death ligand 1 (PD-L1) therapeutic antibodies\n\n          -  Malignancies other than NSCLC within 5 years prior to randomization, with the\n             exception of those with a negligible risk of metastasis or death (e.g., expected\n             5-year OS greater than [>] 90 percent [%]) treated with expected curative outcome\n             (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell\n             skin cancer, localized prostate cancer treated surgically with curative intent, ductal\n             carcinoma in situ treated surgically with curative intent)\n\n          -  History of severe allergic, anaphylactic, or other hypersensitivity reactions to\n             chimeric or humanized antibodies or fusion proteins\n\n          -  Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells\n             or any component of the atezolizumab formulation\n\n          -  History of autoimmune disease, including but not limited to myasthenia gravis,\n             myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,\n             inflammatory bowel disease, vascular thrombosis associated with antiphospholipid\n             syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome,\n             multiple sclerosis, vasculitis, or glomerulonephritis\n\n          -  Positive test for human immunodeficiency virus (HIV)\n\n          -  Participants with active hepatitis B (chronic or acute; defined as having a positive\n             hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C\n\n          -  Active tuberculosis\n\n          -  Significant cardiovascular disease, such as New York Heart Association cardiac disease\n             (Class II or greater), myocardial infarction, or cerebrovascular accident within the\n             previous 3 months, unstable arrhythmias, or unstable angina\n\n          -  History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis\n             obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active\n             pneumonitis on screening chest CT scan\n\n          -  Prior allogeneic bone marrow transplantation or solid organ transplant\n\n          -  Any other diseases, metabolic dysfunction, physical examination finding, or clinical\n             laboratory finding giving reasonable suspicion of a disease or condition that\n             contraindicates the use of an investigational drug or that may affect the\n             interpretation of the results or render the participant at high risk from treatment\n             complications\n\n          -  Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC)\n             assay from other clinical studies (e.g., participants whose PD-L1 expression status\n             was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1\n             antibodies but were not eligible are excluded)\n\n        Specific Exclusions for Pemetrexed Treatment\n\n        - Participants with squamous cell histology\n\n        Exclusion Criteria for Randomized Phase\n\n          -  Signs or symptoms of infection within 14 days prior to randomization (severe infection\n             within 28 days prior to randomization), including but not limited to hospitalization\n             for complications of infection, bacteremia, or severe pneumonia\n\n          -  Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to\n             randomization\n\n          -  Major surgical procedure within 28 days prior to randomization or anticipation of need\n             for a major surgical procedure during the course of the study\n\n          -  Administration of a live, attenuated vaccine within 28 days prior to randomization or\n             anticipation that such a live attenuated vaccine will be required during the study\n\n          -  Treatment with systemic immunostimulatory agents (including but not limited to\n             interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is\n             longer, prior to randomization: Prior treatment with cancer vaccines is allowed\n\n          -  Treatment with systemic corticosteroids or other immunosuppressive medications\n             (including but not limited to prednisone, dexamethasone, cyclophosphamide,\n             azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF]\n             agents) within 14 days prior to randomizationXx_NEWLINE_xXPrior participation, i.e., receipt of study medication, in this study;Xx_NEWLINE_xXPlacement of a subcutaneous venous access device within 7 days prior to the first dose of study treatment unless the procedure is judged of low risk of bleeding.Xx_NEWLINE_xXPretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registrationXx_NEWLINE_xXInclusion Criteria:\n\n          -  Be willing and able to provide written informed consent for the trial.\n\n          -  Over 18 years of age on day of signing informed consent.\n\n          -  Have histologically confirmed muscle invasive disease of the urinary bladder, renal\n             pelvis, or ureters.\n\n          -  Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial\n             carcinoma with mixed histology/features.\n\n          -  Clinical stage cT2-4aN0M0. Please see exclusion criteria for acceptable N0\n             determination/lymph node size.\n\n          -  Have a surgical evaluation that documents the plan for multimodality therapy with a\n             consolidative radical cystectomy or nephroureterectomy.\n\n        NOTE on surgical intent: Criteria for acceptable surgical risk are not defined and per\n        treating urologist. Minimum guidance on surgical intent includes subjects who do not have\n        significant cardiovascular disease such as NHYA class III or IV heart failure, unstable\n        arrhythmias or angina, active CAD, and/or EF<25%. Specific diagnostic testing to determine\n        surgical intent is not required and per treating urologist or oncologist discretion.\n\n          -  Have an archived tumor block available to submit unstained slides for PD-L1\n             expression, basal and luminal subtype analysis; MANDATORY. If slides are not\n             available, a biopsy is strongly encouraged to obtain tissue for submission\n\n          -  Subjects on full dose anticoagulants must be on a stable regimen of warfarin or low\n             molecular weight heparin (LMWH) for at least two weeks.\n\n          -  Female subjects of childbearing potential must have a negative urine or serum\n             pregnancy test within 72 hours prior to study registration. If the urine test is\n             positive or cannot be confirmed as negative, a serum pregnancy test is required.\n\n          -  Female subjects of childbearing potential must be willing to use 2 methods of birth\n             control, be surgically sterile, or abstain from heterosexual intercourse for the\n             course of the study and through 120 days after the last dose of study medication.\n             NOTE: Subjects of childbearing potential are those who have not been surgically\n             sterilized or have not been free from menses for > 1 year.\n\n          -  Male subjects must agree to use a barrier method of male contraception starting with\n             the first dose of study therapy and through 120 days after the last dose of study\n             therapy.\n\n        COHORT I - CISPLATIN-ELIGIBLE:\n\n        In addition to the inclusion criteria listed above, Cohort I subjects must satisfy all of\n        the following criteria:\n\n          -  Glomerular filtration rate (GFR) or creatinine clearance (Ccr) ? 50 mL/min. (24 hour\n             urine preferred). The cisplatin dose will be split over two days for values between\n             50-59 mL/min\n\n          -  ECOG PS 0, 1 (and not 2)\n\n          -  Hearing impaired ? grade 1 (may or may not be enrolled in a monitoring program)\n\n          -  Peripheral neuropathy ?grade 1\n\n        COHORT II - CISPLATIN-INELIGIBLE:\n\n        In addition to the inclusion criteria listed above, Cohort II subjects must also meet any\n        ONE of the following criteria:\n\n          -  GFR or Ccr: 30-49 (24 hour urine preferred).\n\n          -  ECOG PS 2\n\n          -  Hearing impaired ?grade 2 as assessed by treating physician (may or may not be\n             enrolled in a monitoring program).\n\n          -  Peripheral neuropathy of Grade 2-4\n\n        Exclusion Criteria:\n\n        Subjects may not have any of the following:\n\n          -  A non-surgical approach recommended by the treating urologist due to any reason.\n             Criteria for surgical intent are not defined and, rather, suitability is determined\n             and documented by the subject's treating urologist. Minimum guidance on surgical\n             intent includes subjects who do not have significant cardiovascular disease such as\n             NHYA class III or IV heart failure, unstable arrhythmias or angina, active CAD, and/or\n             EF<25%. Specific cardiopulmonary diagnostic testing to determine surgical intent is\n             not required and per treating urologist or oncologist discretion.\n\n          -  Has abdomino-pelvic short axis lymph node of ?15mm without biopsy. NOTE: A subject\n             with a staging biopsy proving a non-neoplastic process/N0 will meet inclusion.\n\n          -  Is currently participating in or has participated in a study of an investigational\n             agent or using an investigational device within 28 days prior to study registration.\n\n          -  Has a diagnosis of immunodeficiency or received systemic steroid therapy or any other\n             form of immunosuppressive therapy within 7 days prior to study registration. Subjects\n             on steroids for physiologic replacement due to a non-cancer related cause would not be\n             excluded.\n\n          -  Has had a prior monoclonal antibody ? 28 days prior to study registration or who has\n             not recovered (i.e., ? Grade 1 or at baseline) from adverse events due to agents\n             administered more than 28 days earlier.\n\n          -  Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy for\n             urothelial carcinoma.\n\n          -  Has a known additional malignancy that is progressing or required treatment ? 48\n             months of study registration. Exceptions include basal cell carcinoma of the skin,\n             squamous cell carcinoma of the skin, in situ cervical cancer that has undergone\n             potentially curative therapy, stable (as defined by PSA change, checked within 30\n             days) and untreated very low-risk or low-risk prostate cancer defined by current NCCN\n             guidelines.\n\n          -  Has known active central nervous system (CNS) metastases and/or carcinomatous\n             meningitis. Brain imaging is not required and per discretion of treating physician.\n\n          -  Has an active autoimmune disease requiring systemic treatment within the past 3 months\n             or a documented history of clinically severe autoimmune disease, or a syndrome that\n             requires systemic steroids or immunosuppressive agents. NOTE: Subjects with vitiligo\n             or resolved childhood asthma/atopy would be an exception. Subjects that require\n             intermittent use of bronchodilators or local steroid injections would not be excluded\n             from the study. Subjects with hypothyroidism stable on hormone replacement or\n             Sjogren's syndrome will not be excluded from the study.\n\n          -  Has known evidence of interstitial lung disease or active, non-infectious pneumonitis.\n\n          -  Has an active infection requiring systemic therapy.\n\n          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality\n             that might confound the results of the trial, interfere with the subject's\n             participation for the full duration of the trial, or is not in the best interest of\n             the subject to participate, in the opinion of the treating investigator.\n\n          -  Has known psychiatric or substance abuse disorders that would interfere with\n             cooperation with the requirements of the trial.\n\n          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the\n             projected duration of the trial, starting with the pre-screening or screening visit\n             through 120 days after the last dose of trial treatment.\n\n          -  Has received therapy with hematopoietic growth factor such as G-CSF or GM-CSF in the\n             14 days prior to registration.\n\n          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or\n             anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including\n             ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation\n             or checkpoint pathways).\n\n          -  Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n\n          -  Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA\n             [qualitative] is detected).\n\n          -  Has received a live vaccine within 30 days prior to the first dose of trial treatment.\n             NOTE: Examples of live vaccines include, but are not limited to, the following:\n             measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral)\n             vaccines. Seasonal influenza vaccines for injection are generally killed virus\n             vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are\n             live attenuated vaccines, and are not allowed.Xx_NEWLINE_xXPrior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drugXx_NEWLINE_xXThe patient has been treated with radio- or toxin-immunoconjugates within 70 days of the first dose of the study drugXx_NEWLINE_xXPatient-reported cigarette use within the past 30 daysXx_NEWLINE_xXScheduled to receive paclitaxel at a dose >= 70 mg/m^2 =< 14 days from randomizationXx_NEWLINE_xXUse of long acting opioids pre-operatively 28 days prior to day of surgeryXx_NEWLINE_xXPatients continuously taking systemic steroids within the last 15 daysXx_NEWLINE_xXChronic systemic corticosteroid use (> 14 days) at the time of study enrollmentXx_NEWLINE_xXPatients must currently be taking a third-generation aromatase inhibitor (AI) – anastrozole, letrozole, or exemestane for at least the previous 30 days prior to registration with plans to continue for at least an additional 1 year after registration; patients may have switched AIs provided that they have been on a stable dose for at least 30 days; concurrent trastuzumab (Herceptin) is allowedXx_NEWLINE_xXPatients must not be on narcotics within 14 days of registrationXx_NEWLINE_xXPatients must not have received topical analgesics (e.g., capsaicin preparations) or any other analgesics (e.g., opiates, tramadol, with the exception of nonsteroidal anti-inflammatory drugs [NSAIDs], combination NSAIDs, and acetaminophen) within 14 days prior to registrationXx_NEWLINE_xXPrestudy history and physical must be obtained within 180 days prior to registrationXx_NEWLINE_xXUse of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)Xx_NEWLINE_xXPrior history of acupressure useXx_NEWLINE_xXSubject is receiving or is less than 30 days since ending other experimental device or drug (no marketing authorization for any indication)Xx_NEWLINE_xXHistory/physical examination within 30 days prior to registrationXx_NEWLINE_xXUse of any other experimental drug or therapy within 28 days of baselineXx_NEWLINE_xXESA therapy within the 28 days prior to randomization.Xx_NEWLINE_xXInsomnia present for >= 30 days per patient reportXx_NEWLINE_xXCorticosteroid within the past 30 days prior to registration on this study for greater than one week durationXx_NEWLINE_xXPsychostimulant use in the past 30 days prior to registrationXx_NEWLINE_xXDisease response must be confirmed with repeat laboratory studies at least 30 days apartXx_NEWLINE_xXParticipation in another clinical study within 28 days of the day chemotherapy is initiated, in which the study drug or device may influence hematopoiesis. Co-enrollment in another study is allowed in cases where the investigational therapy under study is a version of an acceptable chemotherapy regimen for this study per the inclusion criteria.Xx_NEWLINE_xXProlonged chest infection, defined as lung consolidation that requires hospitalization and greater than 10 days of antibiotics 30 days prior to surgery.Xx_NEWLINE_xXPatients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 +/- 2 days through day 28 +/- 2 days)Xx_NEWLINE_xXCryoablation should be performed within 14 days of baseline evaluationsXx_NEWLINE_xXGENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of enrollment onto a subprotocol, the following general criteria for initiation of therapy will be required:\r\n* Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer directed therapy prior to enrollment to the subprotocol; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n** Cytotoxic chemotherapy or other anticancer agents known to be myelosuppressive: for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n*** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** Anticancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC]): >= 7 days after the last dose of agent; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n** Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n** Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n** Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n** Stem cell infusions (with or without TBI):\r\n*** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of GVHD\r\n*** Autologous stem cell infusion including boost infusion: >= 42 days\r\n** Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)\r\n** X-ray therapy (XRT)/External Beam Irradiation including Protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n** Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapyXx_NEWLINE_xXPrevious blood transfusion (7 days prior to genetic testing)Xx_NEWLINE_xXWomen scheduled for screening WBUS and a screening full field digital mammography (FFDM) on the same day or within the following 30 days of each otherXx_NEWLINE_xXWomen scheduled for WBUS and screening CEDM on the same day or within 30 days of one anotherXx_NEWLINE_xXAny women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each otherXx_NEWLINE_xXWomen who have a screening digital mammogram on the day of CESM or within 365 days priorXx_NEWLINE_xXPatients must have no significant medical or psychiatric condition that would preclude study completion; tests and exams for this determination should be completed within 28 days prior to registrationXx_NEWLINE_xXSerum creatinine =< 1.5 x IULN obtained within 28 days prior to registrationXx_NEWLINE_xXUse of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of enrollmentXx_NEWLINE_xXUse of any other blood pressure lowering medication for treatment of hypertension within 30 days of enrollment except calcium channel blockers and diureticsXx_NEWLINE_xXDigital mammogram within 365 days prior to pre-registrationXx_NEWLINE_xXWomen who have taken metformin within the past 90 daysXx_NEWLINE_xXSubjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollmentXx_NEWLINE_xXAll clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated below.Xx_NEWLINE_xXWilling to discontinue taking nonsteroidal anti-inflammatory drugs (NSAIDS) for 30 days prior to initiation of and during intervention; exception: use of =< 81 mg daily or =< 650 mg weekly aspirin is allowedXx_NEWLINE_xXSubjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollmentXx_NEWLINE_xXVitamin D supplementation > 2,000 IU/day of vitamin D within 30 days prior to enrollment in step 1Xx_NEWLINE_xXCurrently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 daysXx_NEWLINE_xXPatients who have undergone a non-myeloablative stem cell transplant must have > 80% donor hematopoiesis within 30 days of study enrollment; chimerism within 30 days of study entry must be greater than, equal to, or no more than 5% less than the chimerism measured at approximately day +30 (if performed)Xx_NEWLINE_xXNo donor lymphocyte infusion (DLI) prior to day 100, and no plans for a DLI in the upcoming 30 daysXx_NEWLINE_xXUse of ASA or NSAIDs for more than 5 days per month within 3 months of enrollmentXx_NEWLINE_xXPatients must be at least 28 days post systemic steroids prior to enrollmentXx_NEWLINE_xXGlycosylated hemoglobin measurement (HbA1c) < 5.7% within 90 days of enrollmentXx_NEWLINE_xXWilling to set a quit date in the next 30 daysXx_NEWLINE_xXMotivated to quit within the next 30 days.Xx_NEWLINE_xXCurrent use of a retinol containing agent or any retinoid analogue drug within the last 30 daysXx_NEWLINE_xXReceipt of ART for at least 180 days prior to randomizationXx_NEWLINE_xXPatient who received palonosetron within 1 week prior to administration of study drug.Xx_NEWLINE_xXIndividuals who have used photosensitizing drugs within the last 30 days prior to study enrollment, or who will be using a photosensitizing drug during the time of the study, will not be eligibleXx_NEWLINE_xXIndividuals who have used any topical medication other than emollients on the test area within 30 days prior to study enrollment; if a study participant requires topical medication to the test area during the study, they will be withdrawn from the study.Xx_NEWLINE_xXIndividuals who have used retinoids, steroids, 5-fluorouracil, Levulan, Vaniqua (eflornithine), Solaraze, or imiquimod (Aldara®) anywhere on the body within 30 days prior to enrollment; subjects may be reconsidered for eligibility 30 days after the last topical treatment with such medicationsXx_NEWLINE_xXRecent quitters (have not smoked in past 7 days)Xx_NEWLINE_xXProven, probable or possible IFI within the previous 30 daysXx_NEWLINE_xXReceived rolapitant within 21 days prior to study enrollmentXx_NEWLINE_xXUse of laxatives within the past 7 daysXx_NEWLINE_xXUse of chronic laxatives (>= 30 consecutive days)Xx_NEWLINE_xXChronic administration (defined as daily or every other day for continued use > 14 days) of systemic glucocorticoids within 28 days of the first planned dose of PROSTVAC-V/F; use of inhaled steroids, nasal sprays, and all topical preparations (creams, solutions, gels, ointments, etc.) for up to 5% of the body surface area is allowedXx_NEWLINE_xXUse of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participationXx_NEWLINE_xXImaging results from within 30 days prior to transplant (used as baseline measure for documentation of disease status); results may be obtained at a time point greater than 30 days from transplant if obtained per the patient’s standard of care and with prior sponsor approvalXx_NEWLINE_xXIn patients without cGVHD, transplant must have occurred 80-150 days before the start of study drugXx_NEWLINE_xXPatients may have received no more than one donor lymphocyte infusion (DLI), DLI must have been administered > 6 weeks prior to enrollment on study, and no plans for a DLI in the upcoming 30 daysXx_NEWLINE_xXPatients with a prior thoracotomy within 1 week of study registrationXx_NEWLINE_xXWomen must not be breastfeeding, WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) apixaban plus 5 half-lives of study drug apixaban (2.5 days) plus 30 days (duration of ovulatory cycle) for a total of 32.5 days post-treatment completionXx_NEWLINE_xXSmoke on >= 25 days of the past 30 daysXx_NEWLINE_xXUse of tobacco products other than cigarettes in past 30 daysXx_NEWLINE_xXCurrent use of certain medications: (1) smoking cessation medications (meds) (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT, Chantix, (2) certain medications used to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (amitriptyline), (3) a case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however as needed (PRN) use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month’s duration)Xx_NEWLINE_xXPatient has used any investigational drugs, biologics, or devices within 14 days prior to study treatment or plans to use any of these during the course of the studyXx_NEWLINE_xXBaseline mammogram performed within 90 days prior to study entry, done on a digital mammography machine, that are reported as normal or benign.Xx_NEWLINE_xXReceipt of locoregional therapy (LRT) with verification of complete response at least 30 days following treatmentXx_NEWLINE_xXSmoke one or more cigarettes on 25 out of the past 30 daysXx_NEWLINE_xXChronic immunosuppressive therapy within 30 days of screeningXx_NEWLINE_xXInflammatory eye disease requiring steroid treatment within 28 days of screeningXx_NEWLINE_xXSmoke cigarettes 25 of the past 30 days (not including days spent in the hospital)Xx_NEWLINE_xXAny prior surgery to the prostate within 30 days of baseline procedures; NOTE: Biopsies are not considered surgeriesXx_NEWLINE_xXThyroid stimulating hormone (TSH) =< 1.5 times ULN, within 30 days prior to enrollmentXx_NEWLINE_xXHas received any formulation of POS within prior 10 daysXx_NEWLINE_xXHas participated in any Phase 1 Investigational New Drug (IND) study within prior 30 days or expects to do so within the following 60 daysXx_NEWLINE_xXGreater than 30 days from completion of cytotoxic and biologic therapy and less than 120 days from previous therapy.Xx_NEWLINE_xXCertain medicines and herbal remedies taken during the 7 days before the start of study drugXx_NEWLINE_xXLeukocyte count >= 3,000/microliter obtained =< 45 days prior to randomizationXx_NEWLINE_xXFirst dose of study medication must be greater than 30 days from completion of cytotoxic and antibody therapy and less than 120 days from previous therapyXx_NEWLINE_xXUse of any of the following within 28 days prior to the first dose of IP (INVESTIGATIONAL PRODUCT):Xx_NEWLINE_xXPregnant, planning to become pregnant starting from 28 days prior to receiving CC-486 throughout your participation in the study, and for at least 90 days following your last dose of study treatment, or breast-feeding femalesXx_NEWLINE_xXPotassium within institutional range, obtained within 14 days prior to treatment startXx_NEWLINE_xXBilirubin =< ULN (unless documented Gilbert's disease), obtained within 14 days prior to treatment startXx_NEWLINE_xXSignificant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose of study drugXx_NEWLINE_xXSystemic anti-tumor therapy within 14 days, or plasmapheresis within 7 days prior to the first dose of study drugXx_NEWLINE_xXUse of enzyme-inducing anti-epileptic drugs (EIAED) within 7 days prior to the first dose of study drug.Xx_NEWLINE_xXAnti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose provided all treatment-related adverse events have resolved or have been deemed irreversible, with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 7 days before beginning the administration of BBI608.Xx_NEWLINE_xXHave received any investigational new drug within the past 30 days or planning to receive such during the study periodXx_NEWLINE_xXPatients should agree to not donate blood while participating in this study or for at least 90 days following the last infusion of durvalumab or tremelimumabXx_NEWLINE_xXAdministration of chemotherapy or any investigational drug in the 28 days prior to receiving the first dose of treatment.Xx_NEWLINE_xXSubject has concurrent participation in any interventional studies within 14 days of first dose of study drug.Xx_NEWLINE_xXOn a stable or decreasing dose of dexamethasone for the previous 7 daysXx_NEWLINE_xXUse of enzyme-inducing antiepileptic drugs (EIAEDs) within 7 days prior to the first dose of study drugXx_NEWLINE_xXTreatment with brivudine, sorivudine, or its chemically-related analogs ? 28 days prior to the date of RandomizationXx_NEWLINE_xXAllogeneic HSCT within 90 days of leukapheresisXx_NEWLINE_xXPatients who’ve received a therapeutic course of antibiotics within 15 days prior to thoracic surgeryXx_NEWLINE_xXPatients must not have been taking steroids or are on a stable dose of steroids for at least 14 days before enrollmentXx_NEWLINE_xXReceipt of any investigational agents within 30 days prior to commencing study treatmentXx_NEWLINE_xXVitamin D supplementation > 2,000 IU/day of vitamin D within 30 days prior to enrollmentXx_NEWLINE_xXWill be receiving stem cell rescue therapy in conjunction with study-related course of emetogenic chemotherapy or during the 14 days following administration of fosaprepitant/placebo for fosaprepitantXx_NEWLINE_xXInpatients who have central venous catheter (CVC) that has been in place for at least 14 days and is expected to remain in place at least for 30 days after enrollmentXx_NEWLINE_xXReceived the following within 30 days before screening or plan to receive during the study: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent or biological therapyXx_NEWLINE_xXHas severe hepatic insufficiency within 5 days before randomizationXx_NEWLINE_xXIs pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 90 days after the last dose of study drugXx_NEWLINE_xXIs expecting to donate eggs or sperm from the time of consent through 90 days after the last dose of study drugXx_NEWLINE_xXUse of ASA or NSAIDs for more than 5 days per month within 3 months of enrollmentXx_NEWLINE_xXWillingness to consume meals/snacks provided for 28 consecutive daysXx_NEWLINE_xXSmoke on >= 25 days of the past 30 daysXx_NEWLINE_xXUse of tobacco products other than cigarettes in past 30 daysXx_NEWLINE_xXhas practiced adequate contraception for 30 days prior to vaccination, andXx_NEWLINE_xXUse of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subject's underlying disease, is allowed.Xx_NEWLINE_xXECOG Performance Score of 0 or 1 within 14 days prior to registrationXx_NEWLINE_xXPatients taking Vitamin D supplements during the study, unless they have been taking Vitamin D supplements for 30 days or more prior to the start of the study and that the dose of the Vitamin D supplement remain the same throughout the study.Xx_NEWLINE_xXSubjects must agree to abstain from dietary sources of glucosinolates and isothiocyanates beginning three days prior to study and throughout duration of the active study (28 days); participants will be asked to keep a food diary; patients will be asked to record instances of accidental ingestion of these foods, with patients being removed from the study if this occurs 7 or more timesXx_NEWLINE_xXUse of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entryXx_NEWLINE_xXhas practiced adequate contraception for 30 days prior to vaccination, andXx_NEWLINE_xXUse of monoamine oxidase inhibitors within 14 days of study entryXx_NEWLINE_xXProgressive enhancement (> 25% increase in contrast enhancing volume compared to nadir or a new measurable lesion) on MRI performed within 28 days of registration, and >= 42 days since completion of standard radiation/temozolomide therapy; measurable enhancement is defined as two perpendicular in-plane diameters of at least 10 mm, and at least 10 mm in the 3rd orthogonal directionXx_NEWLINE_xXPatients must be registered on study within 100 days after core needle biopsyXx_NEWLINE_xXPatient registered on study more than 100 days since the date of core needle biopsyXx_NEWLINE_xXPrior treatment with Food and Drug Administration (FDA)-approved or investigational biologics or novel molecularly target therapies, including oral or IV formulations, are permitted; patients must be off prior targeted therapy for at least 14 days prior to study biopsyXx_NEWLINE_xXPatient must be maintained on a stable corticosteroid regimen for 5 days prior to each MR-PET scanXx_NEWLINE_xXPatients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours (h) after their final CEUS examXx_NEWLINE_xXSevere/uncontrolled inter current illness within the previous 28 days prior to PET scanXx_NEWLINE_xXHave CT scans within 30 days suitable for use with the virtual bronchoscopic systemXx_NEWLINE_xXReceived an investigational drug within 30 days prior to first dose of panitumumab-IRDye800Xx_NEWLINE_xXReceived an investigational drug within 30 days prior to first dose of panitumumab-IRDye800Xx_NEWLINE_xXPatients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours (h) afterwardsXx_NEWLINE_xXSubject has previously received VM110, or any other investigational product in the past thirty daysXx_NEWLINE_xXSUB-STUDY I: At least 7 days after most recent prostate biopsyXx_NEWLINE_xXSUB-STUDY III: Investigational therapy for prostate cancer less than 28 days prior to study PET imagingXx_NEWLINE_xXSubject who have received treatment of any somatostatin analogue, including Somatuline® Autogel® /Depot®, Sandostatin® LAR within 28 days, and Sandostatin® within 24 hours prior to first 68Ga-OPS202 administrationXx_NEWLINE_xXPlatelets >= 100,000/mm^3, obtained within 14 days prior to C11-AMT PET scanXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN, obtained within 14 days prior to C11-AMT PET scanXx_NEWLINE_xXAlbumin >= 2.5 mg/dL, obtained within 14 days prior to C11-AMT PET scanXx_NEWLINE_xXAdjuvant anticancer treatments are allowed if at least 30 days has elapsed between the infusion/injection and C11-AMT PET scan as part of this studyXx_NEWLINE_xXParticipation in any other study in last 30 daysXx_NEWLINE_xXPatients who are on anticoagulants or high dose aspirin therapy that cannot be safely stopped for greater than 10 days prior to treatment should be excluded to limit increased risk for urinary obstructionXx_NEWLINE_xXPlasma creatinine in excess of 180 umol/L within 30 days prior to surgeryXx_NEWLINE_xXSubjects will receive the standard Food and Drug Administration (FDA)-approved dose and schedule of 5-azacytidine; this dose is 75 mg/m^2 SC or intravenously (IV) daily for seven days with cycles repeated every 28 daysXx_NEWLINE_xXFemale subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drugXx_NEWLINE_xXReceived an investigational drug within 30 days prior to first dose of panitumumab IRDye800Xx_NEWLINE_xXReceived an investigational drug within 30 days prior to first dose of cetuximab IRDye800Xx_NEWLINE_xXPatient must not have evidence of a new CNS hemorrhage greater than 0.5 cm on baseline MRI obtained =< 14 days prior to study enrollmentXx_NEWLINE_xXReceived an investigational drug within 30 days prior to first dose of cetuximab-IRDye800Xx_NEWLINE_xXSurgical intervention within 28 days prior to the first dose of M3541 administrationXx_NEWLINE_xXSystemic corticosteroid therapy within 7 days before enrollment.Xx_NEWLINE_xXInclusion Criteria:\n\n          -  In order to be eligible for participation in this trial, the subject must meet all the\n             following:\n\n               1. Pathologically documented unresectable melanoma, AJCC Stage III or IV. Subjects\n                  must have histological or cytological confirmed diagnosis of unresectable\n                  melanoma with progressive locally advanced or metastatic disease.\n\n               2. Subjects must be refractory to anti-PD-1 monoclonal antibodies (pembrolizumab or\n                  nivolumab either as monotherapy or in combination with other approved checkpoint\n                  inhibitors or targeted therapies according to their approved label) and subjects\n                  must meet all of the following criteria:\n\n                    1. Received at least 4 doses of anti-PD1 mAb (minimum dose of 2 mg/kg or fixed\n                       dose of 200 mg given Q3W for pembrolizumab; minimum dose of 240 mg given Q2W\n                       for nivolumab in monotherapy; minimum dose of 1 mg/kg given Q3W for\n                       nivolumab in combination with ipilimumab)\n\n                    2. Progressive disease after anti-PD1 mAb will be defined according to RECIST\n                       v1.1.\n\n                    3. Documented disease progression within 24 weeks of the last dose of anti-PD1\n                       mAb.\n\n               3. Resolution/improvement of anti-PD1 mAb-related AEs\n\n                    1. No history of common toxicity criteria adverse events (CTCAE) Grade 4 irAEs\n                       from anti-PD1 mAb.\n\n                    2. No history of CTCAE Grade 3 requiring steroid treatment (>10 mg/day\n                       prednisone or equivalent dose) for >12 weeks or CTCAE Grade 2 pneumonitis\n                       regardless of steroid treatment.\n\n                    3. Minimum of 4 weeks (washout period) from the last dose of anti PD1 mAb.\n\n               4. Prior treatment with an approved BRAF inhibitor if BRAF V600 mutation-positive.\n\n               5. Age ? 18 years of age on day of signing informed consent.\n\n               6. Has a performance status of 0 or 1 on the ECOG Performance Scale.\n\n               7. Have measurable disease based on RECIST v1.1, with at least one anatomically\n                  distinct lesion. Lesion or lesions must meet all the following baseline criteria:\n\n                    1. Accessible for electroporation,\n\n                    2. Must be accurately measured in at least one dimension (longest diameter in\n                       the plane of measurement is to be recorded)\n\n               8. Demonstrate adequate organ function as defined below. All screening laboratories\n                  should be performed within 10 days of treatment initiation.\n\n                  System Laboratory Value Hematological Absolute neutrophil count (ANC) ?1.5 ×\n                  109/L Platelets ?100 × 109/L Hemoglobin ?9 g/dL or ?5.6 mmol/L* Renal Creatinine\n                  OR ?1.5 × the upper limit of normal (ULN) OR Measured or calculated** creatinine\n                  clearance (CrCl) Glomerular filtration rate (GFR) can also be used instead of\n                  creatinine or CrCl ? 30 mL/min for patient with creatinine levels >1.5 ×\n                  institutional ULN Hepatic Total bilirubin ?1.5 × ULN OR direct bilirubin ?ULN for\n                  patients with total bilirubin levels > 1.5× ULN Aspartate aminotransferase (AST)\n                  and alanine aminotransferase (ALT) ?2.5 × ULN OR ?5 × ULN for patients with liver\n                  metastases Coagulation International Normalized Ratio (INR) or Prothrombin Time\n                  (PT) ?1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT\n                  or PTT is within therapeutic range of intended use of anticoagulants Activated\n                  Partial Thromboplastin Time (aPTT)\n\n                  * Criteria must be met without erythropoietin dependency and without packed red\n                  blood cell (pRBC) transfusion within last 2 weeks\n\n                  ** Creatinine clearance should be calculated per institutional standard.\n\n               9. Women of childbearing potential must have negative serum or urine pregnancy test\n                  within 72 hours prior to receiving the first study drug administration.\n\n              10. For women of childbearing potential, must be willing to use an adequate method of\n                  contraception from 30 days prior to the first study drug administration and 120\n                  days following last day study drug administration. Spermicide alone is not\n                  considered sufficient in Canada and will not be accepted.\n\n              11. Male patients must be surgically sterile, or must agree to use adequate method of\n                  contraception during the study and at least 120 days following the last day of\n                  study drug administration.\n\n              12. Able and willing to provide written informed consent and to follow study\n                  instructions.\n\n        Exclusion Criteria:\n\n        The subject must be excluded from participating in the trial if meet any of the following:\n\n          1. Subject has disease that is suitable for local therapy administered with curative\n             intent.\n\n          2. Subject with a diagnosis of uveal melanoma.\n\n          3. Subject has a known additional malignancy that is progressing or requires active\n             treatment within the past 3 years. Exceptions include basal cell carcinoma of the\n             skin, squamous cell carcinoma of the skin that has undergone potentially curative\n             therapy or in situ cervical cancer.\n\n          4. Clinically active CNS metastases or non-measurable bone-only metastases. Subjects with\n             previously treated brain metastases may participate provided they are radiologically\n             stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging,\n             clinically stable and without requirement of steroid treatment for at least 14 days\n             prior to first dose of study drug.\n\n          5. Greater than 3 visceral sites of metastases. Liver lesions must meet RECIST v1.1\n             criteria for SD for at least 1 month prior to enrolment.\n\n          6. Subjects with electronic pacemakers or defibrillators.\n\n          7. Subjects who have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2\n             antibodies).\n\n          8. Subjects who have known active Hepatitis B (defined as HBsAg reactive) or Hepatitis C\n             virus infection (defined as HCV RNA [qualitative] is detected)\n\n          9. Subject has a diagnosis of immunodeficiency or is receiving chronic systemic steroid\n             therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form\n             of immunosuppressive therapy within 7 days prior to the first dose of study drug. The\n             use of physiologic doses of corticosteroids may be approved after consultation with\n             the Sponsor.\n\n         10. Subjects who have received a live-virus vaccination within 30 days of the first dose\n             of treatment. Seasonal flu vaccines that do not contain live virus are permitted.\n\n         11. Subject has severe hypersensitivity (?Grade 3) to pembrolizumab and/or any of its\n             excipients.\n\n         12. Subject who have received transfusion of blood products (including platelets or red\n             blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF\n             or recombinant erythropoietin) within 4 weeks prior to study Cycle 1, Day 1\n             (baseline).\n\n         13. Subject has a history of (non-infectious) pneumonitis that required steroids or\n             current pneumonitis.\n\n         14. Subject has a history of interstitial lung disease.\n\n         15. Subject has an active infection requiring systemic therapy.\n\n         16. Subject has a history or current evidence of any condition, therapy, or laboratory\n             abnormality that might confound the results of the trial, interfere with the subject's\n             participation for the full duration of the study, or is not in the best interest of\n             the subject to participate, in the opinion of the treating Investigator.\n\n         17. Subject has not recovered (i.e., ? Grade 1 or at baseline) from adverse events due to\n             a previously administered agent.\n\n         18. Participation in another clinical study of an investigational agent or has used an\n             investigational device within 30 days of screening.\n\n         19. Subjects who have had any targeted small molecule therapy or any immunotherapy after\n             their confirmed progression on anti-PD-1 therapy.\n\n         20. Subject has known psychiatric or substance abuse disorders that would interfere with\n             cooperation with the requirements of the study.\n\n         21. Subjects who are pregnant or breastfeeding, or expecting to conceive or father\n             children within the projected duration of the study, starting with the screening visit\n             through 120 days after the last dose of studytreatment.Xx_NEWLINE_xXHad at least 14 days for prior treatment to clear the body before initiation of DS-3201b administration (except for hydroxyurea that needs only 2 days for clearance)Xx_NEWLINE_xXHas consumed herbs/fruits that may have an influence on pharmacokinetics (PK) of DS-3201b from 3 days (14 days for St. John's wort) prior to the start of the study and throughout the entire studyXx_NEWLINE_xXReceived treatment with anti-CTLA-4 antibody within 30 days prior to the start of CMP-001 dosing on W1D1.Xx_NEWLINE_xXConcurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc.) within 28 days of the first dose of study drugXx_NEWLINE_xXMale subject who is considering fathering a child or donating sperm during the study or for approximately 90 days after the last dose of study drugsXx_NEWLINE_xXInvestigational drug use within 28 days of the first dose of avelumabXx_NEWLINE_xXInclusion Criteria:\n\n        Subjects must satisfy the following criteria to be enrolled in the study:\n\n          1. Subject has eligible disease status:\n\n               1. Newly diagnosed and are undergoing induction therapy prior to undergoing first\n                  Autologous stem cell transplant (ASCT) or\n\n               2. Myeloma patients with prior relapse undergoing first ASCT. or\n\n               3. Myeloma patients with relapsed disease after first ASCT who are undergoing second\n                  ASCT. Subjects must have achieved at least a partial response (PR) prior to\n                  proceeding to ASCT.\n\n          2. Subject is > 18 and ? 70 years of age at the time of signing the informed consent form\n             (ICF).\n\n          3. Subject must understand and voluntarily sign an ICF prior to any study-related\n             assessments/procedures being conducted.\n\n          4. Subject is willing and able to adhere to the study schedule and other protocol\n             requirements.\n\n          5. Performance status of Karnofsky performance status ? 70% or Eastern Cooperative\n             Oncology Group (ECOG) < 2\n\n          6. Ability to be off immunosuppressive drugs for at least 3 days prior to the PNK-007\n             cell infusion. Steroids at the equivalent of no more than 5 mg prednisone per day are\n             permissible.\n\n          7. Be a candidate for ASCT based on institutional practices.\n\n          8. Subjects must have autologous peripheral blood stem cell graft available in storage\n             for additional transplant in the event of engraftment failure.\n\n          9. Female of childbearing potential (FCBP) must:\n\n               1. Have two negative pregnancy tests as verified by the Investigator prior to\n                  starting study therapy. She must agree to ongoing pregnancy testing during the\n                  course of the study, and after the end of study treatment. This applies even if\n                  the subject practices true abstinence* from heterosexual contact.\n\n               2. Either commit to true abstinence* from heterosexual contact (which must be\n                  reviewed at applicable study visits and source documented) or agree to use, and\n                  be able to comply with, effective contraception without interruption, during the\n                  study therapy (including dose interruptions), and for 28 days after\n                  discontinuation of PNK-007.\n\n                  A female of childbearing potential (FCBP) is a female who:\n\n                  1) has achieved menarche at some point, 2) has not undergone a hysterectomy or\n                  bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea\n                  following cancer therapy does not rule out childbearing potential) for at least\n                  24 consecutive months (ie, has had menses at any time in the preceding 24\n                  consecutive months).\n\n         10. Male subjects must:\n\n               1. Practice true abstinence* (which must be reviewed at applicable study visits) or\n                  agree to use a condom during sexual contact while participating in the study,\n                  during dose interruptions and for at least 28 days following PNK-007\n                  discontinuation, even if he has undergone a successful vasectomy. * True\n                  abstinence is acceptable when this is in line with the preferred and usual\n                  lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,\n                  symptothermal, post ovulation methods] and withdrawal are not acceptable methods\n                  of contraception]).\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment:\n\n          1. Subject has plasma cell leukemia.\n\n          2. Subject has non-secretory myeloma.\n\n          3. Subject has previously undergone allogeneic stem cell transplant.\n\n          4. Subject has any significant medical condition, laboratory abnormality, or psychiatric\n             illness that would prevent the subject from participating in the study.\n\n          5. Subject has any condition including the presence of laboratory abnormalities which\n             places the subject at unacceptable risk if he or she were to participate in the study.\n\n          6. Subject has any condition that confounds the ability to interpret data from the study.\n\n          7. Subject has a body weight exceeding 120 kg.\n\n          8. Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or\n             alkaline phosphatase ? 2.5 x the upper limit of normal (ULN) at screening.\n\n          9. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at screening\n             calculated using the Modification of Diet in Renal Disease Study equation.\n\n         10. Subject has a bilirubin level > 2 mg/dL (unless subject has known Gilbert's disease)\n             at screening.\n\n         11. Subject has had prior treatment with biologic antineoplastic agents no less than 7\n             days before PNK-007 infusion and at least 5 half-lives. For agents that have known AEs\n             occurring beyond 7 days after administration (ie, monoclonal antibodies), this period\n             must be extended beyond the time during which acute AEs are known to occur.\n\n         12. Subject is pregnant or breastfeeding.\n\n         13. Subject has new or progressive pulmonary infiltrates or pleural effusion large enough\n             to be detected by chest x-ray or computed tomography (CT) scan.\n\n         14. Subject has active autoimmune disease other than controlled connective tissue disorder\n             or those who are not on active therapy.\n\n         15. Subject has human immunodeficiency virus (HIV) are excluded due to increased risk of\n             lethal infections when treated with myeloablative chemotherapy.\n\n         16. Subject has history of malignancy, other than multiple myeloma (MM), unless the\n             subject has been free of disease for > 3 years from the date of signing the ICF.\n             Exceptions include the following:\n\n               1. Basal cell carcinoma of the skin\n\n               2. Squamous cell carcinoma of the skin\n\n               3. Carcinoma in situ of the cervix\n\n               4. Carcinoma in situ of the breast\n\n               5. Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)\n\n         17. Subject has a history of severe asthma and is presently on chronic medications or has\n             a history of other symptomatic pulmonary disease.\n\n         18. Untreated chronic infection or treatment of any infection with systemic antibiotics\n             within 2 weeks prior to melphalan.\n\n         19. Subject has any other organ dysfunction that will interfere with the administration of\n             the therapy according to this protocol.\n\n         20. Subject has a resting left ventricular ejection fraction (LVEF) of < 35% obtained by\n             echocardiography or multigated acquisition scan (MUGA).\n\n         21. Subject was treated with an investigational product no less than 28 days before\n             PNK-007 infusion. Subject must no longer be a participant in the previous\n             interventional study at the time of the PNK-007 infusion.Xx_NEWLINE_xXAnti-androgenic therapy within 30 days prior to enrollmentXx_NEWLINE_xXHas received an investigational product within the 30 days prior to Lymphoseek administrationXx_NEWLINE_xXReceived an investigational drug within 30 days prior to first dose of cetuximab IRDye800Xx_NEWLINE_xXLaboratory studies must be completed within 28 days prior to pimonidazole administrationXx_NEWLINE_xXPatients must not have received any study therapies prior to registrationXx_NEWLINE_xXScheduled for prostatectomy not earlier than 3 days and not later than 30 days following BR55 administration (with the exception of training cases where this requirement is not applicable)Xx_NEWLINE_xXReceived a prostate biopsy procedure within 30 days before admission into the studyXx_NEWLINE_xXPatients with the use of any investigational product or device, excluding fluorodopa (F-DOPA) scans, within 30 days prior to dosingXx_NEWLINE_xXMedical history, physical exam, and vital signs within 30 days of enrollmentXx_NEWLINE_xXMedically able to undergo primary cytoreductive surgery, at least 14 days and up to 28 days after starting study drug, as determined by treating physicianXx_NEWLINE_xXTreatment with long-acting proton pump inhibitors that cannot be discontinued 3 days prior to the start of study drug and during the course of the studyXx_NEWLINE_xXAdministration of any investigational therapeutic within 30 days of enrollmentXx_NEWLINE_xXPatients not on metformin at the time of study entry must be willing to take metformin extended release (Glucophage XR, 750 mg QD for 4 days, then 750 mg BID for 3-6 days) for a total of 7-10 days prior to surgery\r\n* Patients do not require a diagnosis of diabetes to be enrolled in the studyXx_NEWLINE_xXParticipation in a smoking cessation program in the past 30 daysXx_NEWLINE_xXAt the time of registration, all subjects must be removed >= 28 days from any investigational agentsXx_NEWLINE_xXTaking ibuprofen, naproxen, other non-steroid anti-inflammatory drugs (NSAIDs), steroids (except inhaled steroids) within 14 days of study registrationXx_NEWLINE_xXOther tobacco use within the past year for 7 consecutive days or 14 timesXx_NEWLINE_xXAny NSAIDs or omega-3 free fatty acid supplementation within the last 14 daysXx_NEWLINE_xXHospitalization within 30 days of enrollmentXx_NEWLINE_xXMedically able to undergo primary cytoreductive surgery, at least 7 days and up to 28 days after starting study drug, as determined by treating physicianXx_NEWLINE_xXAbility and willingness to abstain from all medications and dietary supplements for 3 days prior to kava administration, continuing until a minimum of 7 days after kava administration; topical medications and inhaled medications that do not contain steroids are permittedXx_NEWLINE_xXAbility and willingness to completely abstain from alcohol consumption for 3 days prior to kava administration, continuing until a minimum of 7 days after kava administrationXx_NEWLINE_xXHave discontinued all disease-modifying therapy for the primary cancer >28 days prior to initiation of study treatment. In addition, clinically significant toxicities associated with any prior therapy for the primary cancer, including investigational treatments, have resolved or stabilized to Grade ?1 toxicity >28 days prior to initiation of study treatment with the exception of neuropathy, which must have resolved to Grade ?2. Continuation of a stable dose (minimum of 28 days prior to study entry) of denosumab or bisphosphonate is permitted on study.Xx_NEWLINE_xXHave received treatment within 28 days prior to the initial dose of study drug with an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study) for non-cancer indications or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.Xx_NEWLINE_xXHave discontinued all disease-modifying therapy for the primary cancer for 28 days prior to initiation of study treatment.Xx_NEWLINE_xXAre enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study within 28 days of the initial dose of study drug.Xx_NEWLINE_xXPatients must not have signs of bowel perforation necessitating surgery or “acute” abdomen evidenced by peritonitis on physical exam within 2 days prior to registrationXx_NEWLINE_xXRadiographic confirmation of MBO is required prior to registration; scans may have been done before or after admission; scans done prior to admission must have been completed within 14 days prior to admission; computed tomography (CT) scans are preferredXx_NEWLINE_xXPrestudy history and physical must be obtained within 3 days prior to registrationXx_NEWLINE_xXReport tobacco use within the past 7 daysXx_NEWLINE_xXHave anticipated in-patient status for 14 to 20 days from the time of transplant.Xx_NEWLINE_xXHave taken an investigational drug within 30 days of enrollment.Xx_NEWLINE_xXBiologic: ?7 days from anti-neoplastic biologic agentXx_NEWLINE_xXImmunotherapy: ?42 days after completion of immunotherapyXx_NEWLINE_xXSubjects must not have received BLZ-100 within 30 days prior to re-treatmentXx_NEWLINE_xXMen who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for 90 days after study entry (withdrawal of dasatinib), at restart of study drug (dasatinib) and for the duration of treatment with study drug (dasatinib) plus 90 days (duration of sperm turnover) for a total of 90 days post-treatment completionXx_NEWLINE_xXuse of non-cigarette tobacco products (e.g., cigarillos) in the last 30 daysXx_NEWLINE_xXPatients may receive anagrelide for up to 28 days (in countries where the product is registered). Leukapheresis is allowed up to 24 hours prior to the first treatment cycle with omacetaxine.Xx_NEWLINE_xXThe patient has received radiotherapy within 30 days prior to the start of study drug, or has not recovered from the acute toxicities associated with prior approved therapies including investigational drugs.Xx_NEWLINE_xXSubjects who have taken an investigational drug within 30 days of enrollment.Xx_NEWLINE_xXInitiation of new photosensitizing drugs within 30 days of Screening.Xx_NEWLINE_xXdaily (25+ days within past 30) cigarette smoker of >5 cigs/dayXx_NEWLINE_xXExpected survival is > 100 daysXx_NEWLINE_xXSubjects who have taken an investigational drug within 30 days of enrollment.Xx_NEWLINE_xXStable or decreasing dose of corticosteroids over 14 days prior to first MRZ doseXx_NEWLINE_xXPatients must be without seizures for at least 14 days prior to enrollment, and patients who receive treatment with AEDs must be on stable doses for at least 14 days prior to enrollmentXx_NEWLINE_xXClinical laboratory values and other measures as specified below within 28 days before the first dose of study drug:Xx_NEWLINE_xXIs receiving any medication prohibited in combination with study chemotherapies as described in the respective product labels, unless medication was stopped within 7 days prior to randomization.Xx_NEWLINE_xXShould be willing to submit local HSV-1 serostatus within 28 days prior to enrollment.Xx_NEWLINE_xXThrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapyXx_NEWLINE_xXOpen wounds or unhealed fractures within 28 days of starting study treatmentXx_NEWLINE_xXPatients who have received wide field radiotherapy ? 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to starting study treatment or those patients who have not recovered adequately from side effects of such therapyXx_NEWLINE_xXInclusion Criteria:\n\n          -  Eligible patients will be considered for inclusion if they meet all of the following\n             criteria. (All necessary baseline studies for determining eligibility must be obtained\n             within 21 days prior to enrollment.)\n\n               1. Male or female patient who is at least 18 years of age.\n\n               2. Patient has given voluntary written informed consent before performance of any\n                  study-related procedures not part of standard (non-investigational) medical care.\n\n               3. Patient has been previously diagnosed with MM based on standard criteria.\n\n               4. Patient has received:\n\n                    1. At least 2 prior therapies including a proteasome inhibitor (? 2 cycles) and\n                       lenalidomide (? 2 cycles), and\n\n                    2. Has achieved at least stable disease (SD) for ? 1 cycle of treatment on ? 1\n                       prior treatment, and\n\n                    3. Has demonstrated disease progression subsequent to treatment, during or\n                       within 90 days following completion of the most recent therapy.\n\n               5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score\n                  ? 2.\n\n               6. Patient has measurable disease defined as at least 1 of the following:\n\n                    1. Serum M protein ? 0.5 /dL (?5 g/L)\n\n                    2. Urine M protein ? 200 mg/24 hours\n\n                    3. Serum free light chain (FLC) assay: Involved FLC assay ?10 mg/dL (?100 mg/L)\n                       and an abnormal serum FLC ratio (<0.26 or >1.65)\n\n               7. Clinical Laboratory Inclusion Criteria: The following laboratory results must be\n                  met within 14 days (or as stipulated) prior to study drug (treatment)\n                  administration:\n\n                    1. Absolute neutrophil count (ANC) ? 1000 cells/?l (growth factor cannot be\n                       used within the previous 7 days).\n\n                    2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 ×\n                       upper limit of normal (ULN).\n\n                    3. Platelet count ? 50,000/?l (without platelet transfusion in the previous 7\n                       days).\n\n                    4. Total bilirubin ? 1.5 mg/dL.\n\n                    5. Serum creatinine ? 2.0 mL/dL and creatinine clearance ? 40 mL/min\n                       (calculated by the Cockcroft-Gault Equation or per 24 hour urine\n                       collection).\n\n                    6. Serum albumin ? 3.2 g/dL in the absence of receipt of (IV) albumin within\n                       the previous 72 hours.\n\n                    7. Serum creatine phosphokinase (CPK) ? 2.5 × the ULN.\n\n                    8. Serum calcium (corrected for albumin) level at or below the ULN range\n                       (treatment of hypercalcemia is allowed and patient may enroll if\n                       hypercalcemia returns to normal range with standard treatment).\n\n               8. Left ventricular ejection fraction (LVEF) ? institutional lower limit of normal\n                  as measured by multigated acquisition scan (MUGA) scan or 2-dimensional\n                  echocardiography (ECHO) within 28 days prior to start of therapy and no\n                  clinically significant abnormalities on a 12-lead electrocardiogram (ECG).\n\n               9. Females of childbearing potential (FCBP)* must have a negative serum or urine\n                  pregnancy test prior to initiation of the SL-401 Run in Cycle (if required) and\n                  repeated with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to\n                  and again within 24 hours of starting Pomalidomide and must either commit to\n                  continued abstinence from heterosexual intercourse or begin 2 acceptable methods\n                  of birth control, 1 highly effective method and 1 additional effective method at\n                  the same time, at least 28 days before she starts taking Pomalidomide through 30\n                  days after the last dose of Pomalidomide and 60 days after the last dose of\n                  SL-401. FCBP must also agree to ongoing pregnancy testing during the entire\n                  duration of treatment. Men must agree to use a latex or synthetic condom during\n                  sexual contact with a FCBP even if they have had a vasectomy from the time of\n                  signing the informed consent form through 60 days after the last dose of\n                  Pomalidomide or SL-401. These same patients must not donate sperm. All patients\n                  must be counseled at a minimum of every 28 days about pregnancy precautions and\n                  risks of fetal exposure. All patients enrolled into this study, must agree to be\n                  registered in and must comply with all requirements of the Pomalidomide REMS(TM)\n                  program.\n\n                    -  An FCBP is a sexually mature female who: 1) has not undergone a hysterectomy\n                       or bilateral oophorectomy; or 2) has not been naturally postmenopausal for\n                       at least 24 consecutive months (i.e., has had menses at any time in the\n                       preceding 24 consecutive months).\n\n        Exclusion Criteria:\n\n        Patients will be ineligible for this study if they meet any 1 of the following criteria:\n\n          1. The patient has an active malignancy and/or cancer history that may confound the\n             assessment of the study endpoints. Patients with a past cancer history (within 2 years\n             of entry) with substantial potential for recurrence and/or ongoing active malignancy\n             must be discussed with the Sponsor before study entry. Patients with the following\n             neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ\n             (including superficial bladder cancer), cervical intraepithelial neoplasia,\n             organ-confined prostate cancer with no evidence of progressive disease.\n\n          2. Prior therapy with SL-401 or received any investigational drug within the prior 30\n             days or 5 half-lives of the investigational drug, whichever is longer.\n\n          3. Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and\n             immunotherapy) within the prior 14 days except for alkylating agents (e.g., melphalan)\n             within the prior 28 days.\n\n          4. POM-refractory disease (i.e., non-responsive to prior POM [either as monotherapy or in\n             combination] or relapse/progressive disease within 60 days of prior POM (either as\n             monotherapy or in combination). Prior POM exposure is permitted, provided the\n             patient's MM is not considered POM-refractory as defined above.\n\n          5. Primary refractory MM defined as disease that is non-responsive in patients that have\n             never achieved at least stable disease or better with any therapy.\n\n          6. Any > grade 1 (according to the National Cancer Institute [NCI] Common Terminology\n             Criteria for Adverse Events [CTCAE], v.4.03) adverse reaction unresolved from previous\n             treatments or not readily managed and controlled with supportive care. The presence of\n             alopecia of any grade and peripheral neuropathy ? grade 2 without pain is allowed.\n\n          7. Previous allogeneic stem cell transplantation with active graft-versus-host-disease,\n             or treatment with immunosuppressive therapy in the 2 months prior to study entry.\n\n          8. Daily requirement for corticosteroids >10 mg prednisone daily (or equivalent); inhaled\n             corticosteroids are permitted.\n\n          9. Patient is known to be human immunodeficiency virus positive, or have chronic or\n             active hepatitis B (core- or surface antigen-positive) or active hepatitis C\n             infection.\n\n         10. Clinically significant cardiovascular disease (e.g., uncontrolled or any New York\n             Heart Association [NYHA] Class 3 or 4, congestive heart failure, uncontrolled or\n             unstable angina, history of myocardial infarction or stroke within 6 months prior to\n             study entry, uncontrolled hypertension or clinically significant arrhythmias not\n             controlled by medication)\n\n         11. Uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive\n             pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator\n             would put the patient at significant risk for pulmonary complications during the\n             study.\n\n         12. Uncontrolled intercurrent illness including, but not limited to, uncontrolled\n             infection, disseminated intravascular coagulation, or psychiatric illness/social\n             situations that would limit compliance with study requirements.\n\n         13. History of erythema multiforme or severe hypersensitivity to prior Immunomodulatory\n             Drugs (IMiDs) such as thalidomide and lenalidomide.\n\n         14. The patient is receiving medications that are strong inhibitors of CYP1A2. Patients\n             should have discontinued strong CYP1A2 inhibitors (e.g., ciprofloxacin and\n             fluvoxamine) at least 5 half-lives before beginning study drug.\n\n         15. The patient continues to smoke cigarettes, which can induce CYP1A2.\n\n         16. Inability to tolerate thromboprophylaxis.\n\n         17. Pregnant or breast feeding. -Xx_NEWLINE_xXTreatment with other investigational agents less than 14 days prior to study entry.Xx_NEWLINE_xXCLL therapy, with the exception of ibrutinib within the following timeframes:\r\n* Chemotherapy, external beam radiation therapy, anticancer antibodies within 30 days prior to the first dose of drug on this study\r\n* Corticosteroid use >= 20 mg prednisone within 1 week prior to first dose on this study\r\n* Radio- or toxin-conjugated antibody therapy within 10 weeks prior to first dose on this study\r\n* Allogeneic stem cell transplant within 6 months prior to first dose on this studyXx_NEWLINE_xX